DOS TESTES PCR E DA SEGUNDA ONDA (em vídeo)

Experimentei fazer um vídeo explicativo, e com recurso às simulações constante no site do BMJ, sobre a "eficácia" dos testes PCR e os "perigos" que encerram, nomeadamente o número elevado de falsos positivos se se fizerem testes aleatórios a pessoas sem sintomas. E faço a interpretação sobre se os "erros" dos próprios testes não estarão a aumentar artificial e falsamente o número de casos positivos, levando que a segunda onda seja afinal enganadora. Tentei simplificar ao máximo a minha explicação, mas com detalhe suficiente. Perdoem-me se as minhas valências pedagógicas não forem as ideais... Se houver feedback tentarei fazer outros vídeos explicativos. 

Aviso: apenas os primeiros segundos têm um pequeno problema de áudio.

DA PNEUMONIA, DA COVID, DO DOUTOR FILIPE FROES E DA OBSESSÃO QUE NOS MATARÁ

Uma das pessoas que tem "surfado" bem a suposta onda do SARS-CoV-2, assumindo-se como um "Papista da Covid", à espera da recompensa, é o Doutor Filipe Froes. Depois de em Março ter votado no Conselho Nacional de Saúde Pública contra o encerramento das escolas, tem ele, nos últimos tempos, sido um acérrimo defensor do uso de máscaras em todo e qualquer lugar e da gravidade da situação. Parece, quem o vê, que a covid é a única doenças respiratória que mata, e que ele, eminência parda, nunca tal viu. Pois, eu quero acreditar que ele vê bem, mesmo se usa óculos como eu; e que vê todos os anos muito pior do que a covid. Todos os anos ele vê a pneumonia a atacar. E a atacar bem.

Na verdade, eu até aceitaria as mudanças do Doutor Filipe Froes se o tivesse visto, há um ano ou antes, a fazer-se ouvir, lutando a favor de medidas de controlo da "descontrolada" e "imprevisível" pneumonia, que, por exemplo, em Janeiro de 2017 matou diariamente mais do que a covid no seu pico em Abril deste ano.

E que, sistematicamente, nos outros meses, mata habitualmente sempre mais do que a covid anda agora a matar. Por exemplo, este mês de Setembto a covid matou cinco pessoas por dia; as mortes por pneumonia em Setembro de 2017 e 2018 matavam na ordem da dezena por dia.

De facto, eu gostaria de ter visto o Doutor Filipe Froes, e a nossa imprensa, a defender em 2017, ou mesmo antes, medidas preventivas para as pneumonias, que nesse ano mataram 5.596 pessoas. E que também dêsse murros na mesa em 2018 por não ter sido feito nada, resultando na morte de mais 5.724 pessoas pela pneumonia. Não me recordo de o ter visto reagir. E nem de o ver contextualizar a covid e a mostrar como alguma coisa deve ser feito em relaçâo à pneumonia, que nem seja o 8 (como se olhava para a pneumonia) nem o 80 (como se olha agora para a covid).

Infelizmente, a DGS ainda não se preocupou em disponibilizar as mortes por pneumonia em 2019 e em 2020 (este ano terá descido bastante, por causa do distanciamento social), mas analisando os dados não há nenhum sinal de que venha aí uma segunda fatídica onda de mortes por covid, mas sim é expectávelque surja a habitual onda de mortes por pneumonias (e a covid andará à boleia mas sem dramas).Ou seja, o expectável crescimento de mortes seguirá um padrão habitual, sobre o qual o Ministério da Saúde e a Propaganda Mediática (leia-se, imprensa) pouco se importaram em anos anteriores, considerando ser "normal".

A covid, continuo a defender, é uma doença perigosa para os mais idosos e vulneráveis, mas o seu impacte está a ser sobrevalorizado, e com isso se está a subvalorizar um conjunto vasto de cuidados de saúde públicos que causa muitas mais mortes. E está também a asfixiar a Economia (de onde acham que vêm o Orçamento da Saúde senão dos impostos que dependem da actividade económica?). A obsessão pela covid está a matar-nos mais que o SARS-CoV-2.

De resto, deixo-vos aqui mais um gráfico. Só para que possam raciocinar por vocês.

Nota: Este e outros textos podem ser lidos no blog "Nos Cornos da Covid" em https://noscornosdacovid.blogspot.com/ . Os dados da mortalidade por pneumonia (SNS) podem ser consultados aqui: Para obter os dados da mortalidade por pneumonias devem ser seleccionadas as doenças utilizando a classificação ICD do J.12.0 ao J18.9. A mortalidade diária por covid em Setembro refere-se aos primeiros 26 dias.

DO MILHÃO

Amanhã, domingo, dia 27 de Setembro, vai ser um dia deprimente: vai-se chegar à morte 1.000.000 atribuída ao SARS-CoV-2. A imprensa vai andar ululante; e só não entrevistará o defunto número 1.000.000 porque não pode. 

Entretanto, esse milhão representa menos de 2,3% do total das mortes em 2020 em todo o Mundo (terão falecido até amanhã cerca de 43,7 mulhões de pessoas).

A covid, entretanto, terá matado, até amanhã, 0,01% da população mundial existente em 2020. A pneumónica terá matado 1,25% da população mundial há um século.   

Mas isso de contextualizar as coisas não interessa nada, né?

DA CEIFEIRA DESCONTROLADA

O perfil da mortalidade total em Portugal este ano de 2020 parece uma montanha russa. E só um dos picos (Abril) está associado parcialmente à covid.

Sendo que o primeiro está associado à "habitual" gripe, significa que o terceiro, quarto e quinto pico estão associados ao estado actual do SNS, que deixa a Ceifeira ceifar a seu bel-prazer.

Sinceramente, neste estado de coisas, o melhor é tornarmo-nos todos religiosos. Já nem vale a pena correr. Resta-nos apenas confiar na Virgem.

DA PNEUMONIA, MUITO MAIS LETAL NAS CRIANÇAS E JOVENS DO QUE A COVID

Usando dados estatísticos do Centro de Controle e Prevenção de Doenças (CDC), uma agência federal de saúde norte-americana, confirma-se que a mortalidade por pneumonia (como causa de morte) não anda muito longe da da covid, sendo até muito mais elevada na população jovem. 

Por outro lado, numa parte considerável das mortes por infecções respiratóriias envolvendo a covid, não é claro se estas se devem exclsusivamente ao SARS-Cov-2 ou a outros vírus e bactérias (que causam pneumonias), porque muitas pessoas estão "multi-infectadas". Ou seja, não se sabe se morreram com ou por covid.

Sobre isto e muito mais falarei, às 21:30 horas, numa conversa/entrevista que podem acompanhar aqui: https://www.youtube.com/watch?v=clGy5GIEr0A

DA CONVERSA SOBRE COVID

Esta sexta-feira, a partir das 21:30, terei uma conversa/entrevista sobre a covid-19 e sobre muitos outros assuntos paralelos com transmissão ao vivo e em directo no Facebook, Youtube e outras plataformas.

Vejam aqui em baixo:

Facebook

https://www.facebook.com/groups/1379095552370125/

Telegram:

https://t.me/queroemigrar

Youtube:

https://www.youtube.com/c/QueroEmigrar

Bitchute

https://www.bitchute.com/channel/OiveuAE9wezs/

DO POST PARA NÃO SER LIDO MAS SIM PARA SER MEDIDO

Já se fizeram cerca de 600 milhões de testes PCR em todo o Mundo. Em Portugal vamos perto dos 2,5 milhões (quase 1 por cada 4 habitantes). 

Tamanha procura urgente por causa da covid fez com que, em poucos meses, aparecessem, como cogumelos, empresas a desenvolver kits, sem se saber bem da sua qualidade prática, porque não há nenhuma entidade que previamente regule isto e garanta que a sensibilidade a a especificidade dos testes são mesmo as indicadas pelo fabricante. Sobre os laboratórios é outra história. Não vos vou "obrigar" a ler todas as empresas, mas percorram a lista para saber quantas são e para aquilatar do interesse do negócio.

A lista completa está aqui.

 1 -  1drop Inc. 1copy™ COVID-19 qPCR Multi Kit (Korea MFDS EUA - US FDA EUA - Health Canada - Saudi FDA - Sri Lanka NMRA - CE-IVD)

2 -  3B BlackBio Biotech India Ltd TRUPCR®SARS-CoV-2 RT qPCR Kit (India CDSCO - US FDA EUA)

3 -  3D Medicines 3DMed 2019-nCoV RT-qPCR Detection Kit (CE-IVD)

4 -  3D Medicines ANDiS® SARS-CoV-2 RT-qPCR Detection Kit (US FDA EUA - CE-IVD)

5 -  A*ccelerate Technology A*STAR Fortitude Kit 2.0 (Singapore HSA)

6 -  AAZ-LMB COVID-PRESTO® (CE-IVD)

7 -  AB ANALITICA srl REALQUALITY RQ-2019-nCoV (CE-IVD)

8 -  AB ANALITICA srl REALQUALITY RQ-SARS-CoV-2 (CE-IVD)

9 -  AB Dianostic Systems GmbH abia SARS-CoV-2 IgG/IgM (CE-IVD)

10 -  Abace Biotechnology COVID-19 IgG / IgM Antibody Test Kit (CE-IVD)

11 -  Abace Biotechnology Virus Sampling Kit (CE-IVD)

12 -  Abacus Diagnostica GenomEra SARS-CoV-2 Assay Kit (CE-IVD)

13 -  Abbott Diagnostics Inc. ID NOW COVID-19 (US FDA EUA )

14 -  Abbott Laboratories Panbio™ COVID-19 IgG/IgM Rapid Test Device (CE-IVD)

15 -  Abbott Laboratories Abbott Architect SARS-CoV-2 IgG (US FDA EUA - Singapore HSA - Health Canada - CE-IVD)  1  2

16 -  Abbott Laboratories Panbio™ COVID-19 Ag Rapid Test Device (RUO)

17 -  Abbott Laboratories NAVICA™ Mobile App and BINAXNOW™ COVID-19 Ag Card (US FDA EUA)

18 -  Abbott Molecular Inc. Abbott RealTime SARS-CoV-2 EUA test (US FDA EUA - Australia TGA - Brazil ANVISA - Health Canada - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)

19 -  Abbott Molecular Inc. Alinity m SARS-CoV-2 (US FDA EUA - Singapore HSA)

20 -  Absea Biotechnology Ltd The non-invasive MEGA test of SARS-CoV-2 (mucosal swabs) (In development)  1  2

21 -  Abwiz Bio RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) (In development)

22 -  Academia Sinica Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit (In development)

23 -  Access Bio, Inc. CareStart™ COVID-19 MDx RT-PCR (US FDA EUA - CE-IVD)

24 -  Access Bio, Inc. CareStart™ COVID-19 IgM/IgG (US FDA EUA - RUO)

25 -  AccuBioTech Co. Ltd Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette (CE-IVD)

26 -  Accuster Technologies Pvt Ltd Accuster SARS-COV2-RT-PCR test kit (CE-IVD)

27 -  Accuster Technologies Pvt Ltd COVID-19 RAPID IgG/IgM test kit (CE-IVD)

28 -  Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD)

29 -  ACRO Biotech Inc. Família Teste Rápido em Cassete 2019-nCoV IgG/IgM (Brazil ANVISA)

30 -  Actim Oy Actim ELISA SARS CoV-2 IgG/IgM (In development)

31 -  Actim Oy Actim SARS CoV-2 (In development)

32 -  Actim Oy Actim SARS CoV-2 IgG/IgM (In development)

33 -  Acumen Research Laboratories Pte Ltd Acu-Corona (RUO)

34 -  Acumen Research Laboratories Pte Ltd Acu-Corona 2.0 (Singapore HSA)

35 -  Adaltis S.r.l. MOLgen SARSCoV2 Real Time RT PCR (CE-IVD)  1  2

36 -  ADT Biotech LyteStar 2019-nCoV RT-PCR Kit 1.0 (RUO)

37 -  Advagen Biotech Ltd COVID-19 IgG/IgM LF (Brazil ANVISA)

38 -  Advanced Biological Laboratories SA UltraGene Combo2Screen SARS-CoV-2 Assay (South Africa SAHPRA - CE-IVD)

39 -  Advanced Molecular Diagnostics Zena Max – SARS-COV-2 Direct q-PCR Detection Kit (CE-IVD)  1  2

40 -  Advanced Molecular Diagnostics Zena Max – SARS-COV-2 Real Time PCR Detection Kit (CE-IVD)  1  2

41 -  Adversis Pharma GmbH AProof SARS CoV-2 IgG ELISA (CE-IVD)  1  2

42 -  AffinityImmuno Inc. SARS-CoV-2 Neutralizing Antibody Test Kit (RUO)

43 -  Agena Bioscience iPLEX Pro SARS-CoV-2 Panel (RUO)

44 -  AITbiotech abTES COVID-19 qPCR I Kit (Singapore HSA - South Africa SAHPRA - CE-IVD)

45 -  AIVD Biotech Inc. COVID-19 IgG/IgM Rapid Test (colloidal gold-based) (In development)

46 -  Aldatu Biosciences PANDAA qDx SARS-CoV-2 (RUO)

47 -  Alfa Scientific Designs, Inc. Instant-view Plus Covid-19 Antibody Test (CE-IVD)

48 -  AlphaBiolabs Coronavirus test kit - sample collection (CE-IVD)

49 -  altona Diagnostics RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (US FDA EUA - CE-IVD)

50 -  AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 IgG (CE-IVD)

51 -  AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 Ab (CE-IVD)

52 -  AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 IgM (CE-IVD)

53 -  AMEDA Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 IgG/IgM (CE-IVD)

54 -  AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)

55 -  AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus IgM combo test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)

56 -  AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)

57 -  AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit (Colloidal Gold) (CE-IVD)

58 -  AmonMed Biotechnology Co., Ltd COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)

59 -  Amoy Diagnostics Co., Ltd AmoyDx® Novel Coronavirus (2019 nCoV) Detection Kit (CE-IVD)

60 -  Amplicon Ltd AmpliTest SARS-CoV-2 (Real Time PCR) (CE-IVD)

61 -  AmpliGene India Biotech Pvt. Ltd AmpEZ Rapid and sensitive Real time COVID-2019 test (RUO)

62 -  AMS UK Ltd COVID-19 Lyophilised Nucleic Acid Kit (CE-IVD)

63 -  AMS UK Ltd COVID-19 IgM ELISA (CE-IVD)

64 -  AMS UK Ltd COVID-19 IgG ELISA (CE-IVD)

65 -  AMS UK Ltd 2019-nCoV IgG/IgM Device (CE-IVD)

66 -  AMS UK Ltd COVID-19 ELISA (total antibody) (CE-IVD)

67 -  AMS UK Ltd COVID-19 Antigen ELISA (CE-IVD)

68 -  Anatolia Geneworks Bosphore Novel Coronavirus (2019-nCoV) Detection Kit (lab-based) (CE-IVD)

69 -  Anbio (Xiamen) Biotechnology Co., Ltd COVID-19 Hybrid Capture Fluorescence Immunoassay Test (China NMPA EUA)  1  2

70 -  Anhui Anlong Gene Technology Co., Ltd Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) (CE-IVD)

71 -  Anhui Deep Blue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (CE-IVD)

72 -  Anhui Deep Blue Medical Technology Co., Ltd Colloidal gold strip for SARS-CoV-2 IgG & IgM (RUO)

73 -  AniCon Labor GmbH Kylt® SARS-CoV-2 Confirmation RT-qPCR (CE-IVD)

74 -  AniCon Labor GmbH Kylt® SARS-CoV-2 Screening RTU RT-qPCR (CE-IVD)

75 -  Anlongen nConV-19 Nucleic Acid qPCR Kit (China NMPA EUA - CE-IVD)

76 -  Anomalous Materials Pte Ltd 2019-nCoV IgG/IgM Rapid Testing Kit (CE-IVD)

77 -  Ansh Labs SARS-CoV2 IgG ELISA (CE-IVD)

78 -  Ansh Labs SARS-CoV2 IgM ELISA (CE-IVD)

79 -  AnyGenes Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) (RUO)

80 -  Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus/MERS-CoV/Influenza Virus A/B Multiple Antigen Detection Kit (RUO)

81 -  Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) (MHRA UK - CE-IVD)

82 -  Applied Biological Materials Inc. GenomeCoV19 Detection Kit (CE-IVD)

83 -  Applied Biological Materials Inc. Sample Collection and Viral Transport Solution (CE-IVD)

84 -  Applied Biological Materials Inc. GenomeCov19 IgM/IgG Rapid Test Kit (CE-IVD)

85 -  Applied Biomedical, LLC Confidence COVID-19 Rapid Test (RUO)

86 -  Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit (US FDA EUA)

87 -  Appolon Bioteck Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) (China NMPA EUA - CE-IVD)

88 -  Aptamer Group Ltd ADx SARS Co V-2 Virus Antigen Rapid Point of Care Test (In development)

89 -  ArcDia International Ltd mariPOC SARS-CoV-2 (CE-IVD)

90 -  Ardent Biomed Guangdong Inc. Ardent Throat Swab Sampling Kit for SARS-CoV-2 (US FDA EUA - CE-IVD)

91 -  Assure Tech. (Hangzhou) Co., Ltd COVID-19 IgG/IgM Rapid Test Device (Brazil ANVISA - CE-IVD)

92 -  Assure Tech. (Hangzhou) Co., Ltd COVID-19 Antigen Rapid Test Device (In development)

93 -  Atila BioSystems, Inc. Atila iAMP COVID-2019 Detection Kit (US FDA EUA - South Africa SAHPRA)

94 -  Ativa Medical Ativa Enhanced Screen (In development)  1  2

95 -  Atlas Medical Atlas COVID-19 S1-RBD IgG Elisa Kit (CE-IVD)

96 -  Atlas Medical Atlas COVID-19 Total Antibody Elisa Kit (CE-IVD)

97 -  Atlas Medical Atlas COVID-19 IgG/IgM Test Cassette (CE-IVD)

98 -  Atlas Medical Atlas COVID-19 Real Time RT-PCR Kit (CE-IVD)

99 -  Atlas Medical Atlas COVID-19 IgM Elisa Kit (CE-IVD)

100 -  Attomarker Ltd Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP (automated) (MHRA UK)

101 -  Augurix SA Simtomax Corona Check IgM/IgG Rapid COVID 19 test (CE-IVD)

102 -  Aura Biotechnologies Ltd Quick COVID-19 Realtime Multiplex PCR (In development)

103 -  Aura Biotechnologies Ltd Quick COVID-19 Colorimetric LAMP PCR (In development)

104 -  Aurora Biomed Inc. SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation (In development)

105 -  AusDiagnostics SARS-CoV-2, Influenza and RSV 8-well (Australia TGA - RUO)

106 -  Autobio Diagnostics Co., Ltd Anti-SARS-CoV-2 (China NMPA EUA - US FDA EUA - Brazil ANVISA - CE-IVD)

107 -  Avioq Bio-Tech Co., Ltd Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) (Brazil ANVISA - RUO)

108 -  Axium Bioresearch Inc. AxiumHealth COVID-19 IgG/IgM Antibody Test (RUO)

109 -  BAG Diagnostics GmbH ViroQ SARS-CoV-2 (CE-IVD)

110 -  Bai-care (Tianjin) Biotechnology Co., Ltd Multiplex Nucleic Acid Detection Kit for Respiratory Pathogens (CE-IVD)

111 -  Baiya Phytopharm, Co, Ltd Baiya Rapid COVID-19 IgM/IgG test kit (In development)

112 -  Bao Ruiyuan Biotech (Beijing) Co., Ltd. Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR (RUO)

113 -  BD BioGX SARS-CoV-2 Reagents for BD MAX™ System (US FDA EUA - Health Canada - Australia TGA - Brazil ANVISA - Singapore HSA)

114 -  Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (ELISA) (CE-IVD)

115 -  Beijing Abace Biology Co., Ltd COVID-19 Antibody (IgG/IgM)Test Kit (Colloidal Gold Immunochromatography) (India CDSCO - CE-IVD)

116 -  Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)

117 -  Beijing Abace Biology Co., Ltd COVID-19 IgG Antibody Test Kit (ELISA) (CE-IVD)

118 -  Beijing Abace Biology Co., Ltd COVID-19 IgM Antibody Test Kit (ELISA) (CE-IVD)

119 -  Beijing Applied Biological Technologies Co., Ltd Multiple Real-Time PCR Kit for Detection of 2019-nCoV (China NMPA EUA - CE-IVD - WHO EUL)

120 -  Beijing Beier Bioengineering Co., Ltd Multiple Real-time PCR kit for Detection of SARS-CoV-2 RNA (In development)

121 -  Beijing Biochem Hengye Science & Technology Development Co., Ltd SARS-CoV-2 Real-Time RT-PCR Kit (RUO)

122 -  Beijing Biogench Biotechnology Co., Ltd Diagnostic Kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) (CE-IVD)

123 -  Beijing Bohui Innovation Biotechnology Automated SarS-CoV-2 NAT (RUO)

124 -  Beijing Bohui Innovation Biotechnology Fully Automated 26 Plex RES Panel Assay (RUO)

125 -  Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgM Antibody Determination Kit (CE-IVD) Europe & Asia Middle East & Africa

126 -  Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG/IgM Antibody Rapid Test Kit (colloidal gold assay) (CE-IVD) Europe & Asia Middle East & Africa

127 -  Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG Antibody Determination Kit (CE-IVD) Europe & Asia Middle East & Africa

128 -  Beijing Diagreat Biotechnologies Co., Ltd Time-Resolved Immunofluorescence Analyzer (CE-IVD) Europe & Asia Middle East & Africa

129 -  Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) (CE-IVD) Europe & Asia Middle East & Africa

130 -  Beijing Genskey Medical Technology Co., Ltd SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe) (RUO)

131 -  Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) IgM/IgG Antibody Rapid Test (Colloidal Gold) (CE-IVD)

132 -  Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) (CE-IVD)

133 -  Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Enzyme-Linked Immunosorbent Assay) (CE-IVD)

134 -  Beijing Hotgen Biotech Co., Ltd Coronavirus disease(COVID-19) Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) (CE-IVD)

135 -  Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) (CE-IVD)

136 -  Beijing Infervision Technology Co. Ltd InferRead CT Pneumonia (In development)

137 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Nucleic Acid Test Kit (CE-IVD)

138 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgM ELISA Test Kit (CE-IVD)

139 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Fluorescence) (CE-IVD)

140 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (CE-IVD)

141 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) (CE-IVD)

142 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)

143 -  Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG ELISA Test Kit (CE-IVD)

144 -  Beijing Kinhawk Pharmaceutical Co., Ltd 2019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method) (RUO)

145 -  Beijing Lepu Medical Technology Co., Ltd SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) (Brazil ANVISA - CE-IVD)

146 -  Beijing Microread Genetics Co.,Ltd COVID-19 (SARS-CoV-2) Detection Kit (LAMP) - lab-based or near-POC (CE-IVD)

147 -  Beijing NaGene Diagnosis Reagent Co., Ltd Multiple Real-Time PCR kit for Detection of 2019-nCoV (China NMPA EUA - CE-IVD)

148 -  Beijing Savant Biotechnology Co., Ltd New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) (Singapore HSA - CE-IVD)

149 -  Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) (India CDSCO - CE-IVD)

150 -  Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Rapid Test (RUO)

151 -  Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ab ELISA (CE-IVD)

152 -  Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 IgM ELISA (CE-IVD)

153 -  Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ab Rapid Test (Australia TGA)

154 -  Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 RT-PCR Kit (RUO - WHO EUL)

155 -  BGI Health (HK) Co. Ltd. Real-time fluorescent RT-PCR kit for detecting 2019 nCoV (US FDA EUA - Australia TGA - China NMPA EUA - Health Canada - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)

156 -  BGI HEALTH (HK) Co., Ltd SARS-CoV-2 Virus IgG Antibody Detection Kit (ELISA) (CE-IVD)

157 -  BGI HEALTH (HK) Co., Ltd SARS-CoV-2 Virus IgM Antibody Detection Kit (ELISA) (CE-IVD)

158 -  BGI HEALTH (HK) Co., Ltd SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold) (CE-IVD)

159 -  Bio Basic Canada Inc. SARS-CoV-2 RT-PCR Detection Kit (CE-IVD)

160 -  Bio-Rad Laboratories Inc. Platelia SARS-CoV-2 Total Ab (US FDA EUA - Australia TGA - Singapore HSA - CE-IVD)

161 -  Bio-Techne Ella / Simple Plex COVID-19 16×4 Standard Panel (RUO)

162 -  Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test (US FDA EUA - CE-IVD)

163 -  Bioeksen R&D Technologies Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit (CE-IVD)

164 -  BioFire Defense, LLC BioFire Respiratory Panel 2.1 (RP2.1) (US FDA EUA - Health Canada - South Africa SAHPRA - Philippines FDA)

165 -  BioFire Defense, LLC BioFire COVID-19 Test (US FDA EUA - Health Canada - Singapore HSA - South Africa SAHPRA)

166 -  Biogate Laboratories Ltd COVID-19 IgG/IgM Ab Rapid Test (RUO)

167 -  Biogenix Inc. Pvt Ltd. SARS CoV-2 IgG/IgM Ab Rapid Test (RUO)

168 -  BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen quantitative assay kit (Enzyme-linked immunoassay) (Brazil ANVISA - CE-IVD)

169 -  BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) (US FDA EUA - CE-IVD)

170 -  BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen assay kit (Colloidal Gold Method) (In development)

171 -  Biolidics Ltd 2019-nCoV IgG/IgM Antibody Detection Kit (Singapore HSA - CE-IVD)

172 -  bioLytical Laboratories Inc. INSTI COVID-19 Self Test (RUO)

173 -  bioLytical Laboratories Inc. INSTI SARS-CoV2 Total Antibody Test (RUO)

174 -  BIOMAXIMA S.A. SARS-CoV-2 Real Time PCR LAB-KIT™ (CE-IVD)

175 -  BIOMAXIMA SA 2019-nCoV IgG/IgM Rapid Test Cassette (India CDSCO - CE-IVD)

176 -  BioMedomics, Inc. COVID-19 IgM-IgG Dual Antibody Rapid Test (India CDSCO - CE-IVD)

177 -  Biomeme COVID-19 Go Strips (US FDA EUA - Health Canada)

178 -  bioMérieux SA SARS-COV-2 R-GENE® (ref 423720) (CE-IVD)

179 -  bioMérieux SA SARS-COV-2 R-GENE® (ref 423717) (RUO)

180 -  bioMérieux SA SARS-COV-2 R-GENE® (ref 423735) (US FDA EUA - South Africa SAHPRA - Philippines FDA)

181 -  BIONEER Corporation AccuPower® COVID-19 Real-Time RT-PCR kit (lab-based automated kit: NCV-1111) (CE-IVD)

182 -  BIONEER Corporation AccuPower® SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122) (Philippines FDA - CE-IVD)

183 -  Bioneer Inc., part of BIONEER Corp. SCVR-2122 AccuPower®SARS-CoV-2 Real-Time RT-PCR Kit (50 tests) (RUO)

184 -  Bionote Inc. NowCheck COVID-19 Ag Test (Korea export - CE-IVD)

185 -  Bionote Inc. NowCheck COVID-19 IgM/IgG Test (Korea export - CE-IVD)

186 -  BIORON Diagnostics GmbH RealLine SARS-CoV-2 (different formats) (CE-IVD)

187 -  BIORON Diagnostics GmbH RealLine SARS-CoV-2 lyo (Str-format) (CE-IVD)

188 -  BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit (US FDA EUA - Korea MFDS EUA - CE-IVD)

189 -  Biosino Bio-Technology and Science Inc SARS-COV-2 Antibody Test (CE-IVD)

190 -  BioSpeedia SAS COVID19SEROSpeed-IgM-IgG (CE-IVD)

191 -  Bioss Inc. SARS-Cov-2 Total Antibody ELISA Kit (RUO)

192 -  Bioss Inc. SARS-Cov-2 IgM Antibody ELISA Kit (RUO)

193 -  Bioss Inc. SARS-Cov-2 Nucleoprotein ELISA Kit (RUO)

194 -  BIOSYNEX SA BIOSYNEX COVID-19 BSS (Brazil ANVISA - Singapore HSA - CE-IVD)

195 -  Biotech & Biomedicine (Shenyang) Group Ltd Real Time PCR Detection Kit For COVID-19 Coronavirus (CE-IVD)

196 -  Biotech & Biomedicine (Shenyang) Group Ltd Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus (CE-IVD)

197 -  BIOTECON Diagnostics GmbH microproof SARS-CoV-2 Screening/Identification Kits (RUO)

198 -  BIOTECON Diagnostics GmbH virusproof SL SARS-CoV-2 Real-time PCR Kit (RUO)

199 -  BIOTECON Diagnostics GmbH Acu-CoronaTM 2.0/3.0 SARS-CoV-2 Real-time PCR Kits (Philippines FDA - RUO)

200 -  BioTNS Co. Ltd COVID-19 RT-PCR PNA KIT (US FDA EUA - Korea MFDS EUA - Philippines FDA - CE-IVD)  1  2

201 -  Blue Cross Bio-Medical (Beijing) Co., Ltd One Step Novel Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (CE-IVD)

202 -  BluSense Diagnostics ApS ViroTrack COVID IgA+IgM/IgG/Total Ig Ab (CE-IVD)

203 -  Boditech Inc. ExAmplar COVID-19 real-time PCR kit (L) (RUO)

204 -  Boditech Inc. AFIAS COVID-19, Viral Antigen (automated) (Philippines FDA - Brazil ANVISA - CE-IVD)

205 -  Boditech Inc. Ichromia COVID-19 Ab, IgM/IgG (manual) (Brazil ANVISA - CE-IVD)

206 -  Boditech Inc. Ichroma COVID-19, viral antigen (manual) (RUO)

207 -  Boditech Inc. AFIAS COVID-19 Ab, IgM/IgG (automated) (Brazil ANVISA - CE-IVD)

208 -  Boditech Inc. NuActor – viral RNA extraction kit (Korea MFDS EUA - CE-IVD)

209 -  Bright Line Research Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test (In development)

210 -  BTNX Inc. Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)

211 -  BTS Consultores S.A.C. CavBio RT-PCR COVID-19 kit V1.0 (In development)  1  2

212 -  Calbiotech, Inc. ErbaLisa COVID-19 IgM ELISA (RUO)

213 -  Calbiotech, Inc. ErbaLisa COVID-19 IgG ELISA (US FDA EUA - Brazil ANVISA - CE-IVD)

214 -  Camtech Diagnostics Pte Ltd Camtech COVID-19 Rapid Test Kit (Singapore HSA - CE-IVD)

215 -  Canary Health Technologies AiroStotleCV19 (Breath VOCs) (In development)

216 -  Cancer Rop Co., Ltd. Q-Sens® 2019-nCoV Detection Kit (CE-IVD)

217 -  Canvax Biotech qMAXSentm Coronavirus (SARS-CoV-2) RT-qPCR Detection Kit (RUO)

218 -  CapitalBio Technology Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) (China NMPA EUA)

219 -  Caspr Biotech Lyo-CRISPR SARS-CoV-2 Kit (In development)

220 -  Caspr Biotech Phantom 1.0 Dx (near-POC) (In development)

221 -  Cell ID Pte Ltd Smart COVID-19 IgM/IgG RDT (CE-IVD)

222 -  Cellex Inc. Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test (US FDA EUA - Australia TGA - Brazil ANVISA - CE-IVD)

223 -  CellSafe LAMPlex RT-qLAMP COVID-19 Detection Assay (Fast Detection) (Korea MFDS EUA - CE-IVD)

224 -  Cepheid Xpert Xpress SARS-CoV-2 (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - South Africa SAHPRA - Philippines FDA - CE-IVD - WHO EUL)

225 -  CerTest Biotec S.L. CerTest SARS-CoV-2 (In development)

226 -  CerTest Biotec, S.L. VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit (Australia TGA - Brazil ANVISA - South Africa SAHPRA - CE-IVD)

227 -  CerTest Biotec, S.L. VIASURE SARS-CoV-2 Real Time PCR Detection Kit (CE-IVD)

228 -  CerTest Biotec, S.L. VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit adapted for BD MAX™ System (CE-IVD)

229 -  Changsha Sinocare Inc. SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method) (CE-IVD)

230 -  Chaozhou Hybribio Biochemistry Ltd COVID-19 Real-Time PCR Kit (manual & automated lab-based) (Brazil ANVISA - CE-IVD - WHO EUL)

231 -  Chengdu Fengji Biotechnology Co., Ltd of China 2019-nCoV Nucleic acid detection kit (multiplex PCR fluorescent probe method) (China NMPA EUA)

232 -  Chil Tibbi Mal. San. Tic. Ltd Sti. Chil COVID-19 IgG/IgM (whole blood/serum/plasma) Rapid Test (CE-IVD)

233 -  ChromaCode, Inc. ChromaCode COVID-19 Six Target Single Well Assay (RUO)

234 -  Clonit quanty-CONV-19 (CE-IVD)

235 -  Co-diagnostics Logix Smart™ Coronavirus Disease 2019 (COVID-19) Kit (US FDA EUA - South Africa SAHPRA - CE-IVD) Technical  Regulatory

236 -  Confirm BioSciences Verasure™ COVID-19 Antigen Rapid Swab Test (RUO)

237 -  Confirm BioSciences Verasure™ Coronavirus (Covid19) IgG & IgM Test (RUO)

238 -  Core Technology Co., Ltd COVID-19 IgM/IgG Ab Test (CE-IVD)  1  2

239 -  Coris BioConcept COVID-19 Ag Respi-Strip (CE-IVD)

240 -  Coyote Bioscience Co., Ltd DirectDetect™ SARS-CoV-2 Detection Kit (China NMPA EUA - CE-IVD)

241 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) Anti-NP IgG ELISA Kit (RUO)

242 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) N qRT-PCR (Taqman™) Detection Kit (RUO)

243 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) Multiplex qRT-PCR Detection Kit (RUO)

244 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) Anti-S1 RBD IgG ELISA Kit (RUO)

245 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) Total Antibody Rapid Test Kit (RUO)

246 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) Spike Protein ELISA Kit (RUO)

247 -  Creative Biolabs SARS-CoV-2 (2019-nCoV) Nucleoprotein Protein ELISA Kit (RUO)

248 -  Creative Diagnostics SARS-CoV-2 IgM ELISA Kit (RUO)

249 -  Creative Diagnostics SARS-CoV-2 IgG ELISA Kit (RUO)

250 -  Creative Diagnostics SARS-CoV-2 Antigen ELISA Kit (RUO)

251 -  Creative Diagnostics SARS-COV-2 Total Antibody ELISA Kit (RUO)

252 -  Credo Diagnostics Biomedical VitaPCR COVID-19 assay (Singapore HSA)

253 -  CTK Biotech, Inc. Aridia COVID-19 Real Time PCR Test (Australia TGA - Philippines FDA - CE-IVD)

254 -  CTK Biotech, Inc. OnSite™ COVID-19 IgG/IgM (Australia TGA - Brazil ANVISA - India CDSCO)  1  2

255 -  Curative Inc. (in conjunction with KorvaLabs, Inc.) Curative-Korva SARS-Cov-2 Assay (US FDA EUA)

256 -  Cytecs GmbH SARS-CoV-2 RT-PCR (CE-IVD)

257 -  DAAN Gene Co., Ltd of Sun Yat-sen University Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit (China NMPA EUA - CE-IVD - WHO EUL)  1  2

258 -  DART Diagnostics DART COVID-19 (manual) (In development)

259 -  Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgM ELISA (CE-IVD)

260 -  Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgA ELISA (CE-IVD)

261 -  Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgG ELISA (CE-IVD)

262 -  Denka Seiken Co. Ltd QuickNavi-COVID19 (In development)  1  2 ,

263 -  Dermoaroma Italy Srl D-Biotech: Real-time RT-PCR Detection Kit for COVID-19 (CE-IVD)

264 -  DIA.PRO Diagnostic Bioprobes Srl COV19CONF.CE - ELISA COVID 19 IgG Confirmatory (CE-IVD)

265 -  DIA.PRO Diagnostic BioProbes Srl COV19G.CE - ELISA COVID 19 IgG (CE-IVD)

266 -  DIA.PRO Diagnostic BioProbes Srl COV19M.CE - ELISA COVID 19 IgM (CE-IVD)

267 -  Diagen Biotechnologic Systems Inc. SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-gene) OneStep R (CE-IVD)

268 -  Diagnostics for the Real World Ltd SAMBA II COVID-19 Test (near-POC NAT) (CE-IVD)

269 -  DiaSorin Molecular, LLC Simplexa™ COVID-19 Direct RT-PCR Kit (US FDA EUA - CE-IVD - WHO EUL)

270 -  DiaSorin SpA LIAISON® SARS-CoV-2 S1/S2 IgG (US FDA EUA - Health Canada - Brazil ANVISA - CE-IVD)

271 -  Diatech Pharmacogenetics EasyPGX® ready SARS-CoV-2 (CE-IVD)

272 -  Diatech Pharmacogenetics Easy® SARS-CoV-2 (CE-IVD)

273 -  Diatheva SRL COVID-19 PCR DIATHEVA Detection kit (CE-IVD)

274 -  Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgG (CE-IVD)

275 -  Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgM (CE-IVD)

276 -  Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgA (CE-IVD)

277 -  Digital Biology Group, Bio-Rad Laboratories, Inc. Bio-Rad SARS CoV-2 ddPCR Assay (US FDA EUA - Philippines FDA - RUO)

278 -  DNA Software, Inc. Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B (In development)

279 -  DNA XPERTS XPERTS COVID19 - FAST RT-PCR KIT, Real time PCR kit for COVID19 detection (RUO)  1  2

280 -  DNA-Technology R&D LLC SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit (CE-IVD)

281 -  DowGene Co., Ltd Dow QuickFinder-G 2019-nCoV Real-time PCR Kit (Korea MFDS EUA - CE-IVD)

282 -  DowGene Co., Ltd Dow QuickFinder 2019-nCoV Real-time PCR Kit (Korea MFDS EUA - CE-IVD)

283 -  DRG International, Inc. COVID-19 lgG, EIA-6146 (CE-IVD)

284 -  DRG International, Inc. COVID-19 lgM, EIA-6147 (CE-IVD)

285 -  DxGen Corp. Epithod®616 COVID-19 IgM/IgG Test Kit (Korea export - CE-IVD)

286 -  Dynamiker Biotechnology (Tianjin) Co., Ltd Novel Coronavirus (2019-nCov) RT-PCR Kit (Philippines FDA - RUO)

287 -  Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019 nCOV IgG/IgM Rapid Test (CE-IVD)

288 -  Eagle Biosciences Inc. COVID-19 IgG ELISA Assay (RUO)

289 -  Eagle Biosciences Inc. COVID-19 IgM ELISA Assay (RUO)

290 -  Ebram Produtos Laboratoriais Ltd CORONAVÍRUS IgG/IgM (COVID-19) (Brazil ANVISA)

291 -  Edinburgh Genetics Limited Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit (CE-IVD)

292 -  Edinburgh Genetics Limited Edinburgh Genetics Complete Whole Blood Collection Kit (RUO)

293 -  Edinburgh Genetics Limited Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined (CE-IVD)

294 -  Edinburgh Genetics Limited Edinburgh Genetics COVID-19 Real-Time PCR Testing Kit (China NMPA EUA - CE-IVD)

295 -  Edinburgh Genetics Limited Edinburgh Genetics Virus Swab Sampling Kit (RUO)

296 -  Elabscience SARS-CoV-2 (2019-nCoV) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma) (RUO)

297 -  Elabscience Novel Coronavirus (SARS-CoV-2) Nucleic Acid Assay Kit (RT-PCR) (RUO)

298 -  Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 CONFIRM RT (CE-IVD)

299 -  Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 BASIC A500 RT (CE-IVD)

300 -  Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 BASIC A RT (CE-IVD)

301 -  Eluceda Limited Eluceda Rapid RNA Covid-9 test (In development)

302 -  EMG Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO)

303 -  En Carta En Carta SARS-CoV-2 (In development)

304 -  ender diagnostics ag enderMASS (CE-IVD)

305 -  ender diagnostics ag enderMOBILE (In development)

306 -  ender diagnostics ag enderLAB (CE-IVD)

307 -  Epitope Diagnostics, Inc. EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit (CE-IVD)

308 -  Epitope Diagnostics, Inc. EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit (CE-IVD)

309 -  Eudipia Co., Ltd EuDx™ COVID-19 Detection Kit (CE-IVD)

310 -  Eurobio Scientific EurobioPlex SARS-CoV-2 Multiplex (CE-IVD)

311 -  EUROIMMUN AG EURORealTime SARS-CoV-2 (US FDA EUA - Australia TGA - South Africa SAHPRA - CE-IVD)

312 -  EUROIMMUN AG Anti-SARS-CoV-2-NCP ELISA (IgG) (CE-IVD)

313 -  EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA) (Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)

314 -  EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) (US FDA EUA - Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)

315 -  Eurospital S.p.A. SARS-COV-2 IgG (CE-IVD)  1  2

316 -  FABPulous/DTwist BV DTwist

317 -  Fast Track Diagnostics Luxembourg S.à r.l., a Siemens Healthineers Company FTD-114 SARS-CoV-2 (manual & lab-based NAT) (US FDA EUA - Singapore HSA - CE-IVD - WHO EUL)

318 -  FemtoDx COVID-19 Rapid Home Nucleic Acid Test (In development)

319 -  Finbiosoft Results Manager (automatic PCR interpretation software) (RUO)

320 -  Fjord Diagnostics SDN BHD Fjord - Viral Transport Medium (VTM, alcohol formulation) (Malaysia MDA - CE-IVD)

321 -  Fjord Diagnostics SDN BHD SEDIPREP COVID-19 (CE-IVD)

322 -  FluroTest LLC CompleTest (In development)

323 -  Fluxergy LLC Fluxergy Sample-to-Answer SARS-CoV-2 RT-PCR (In development)

324 -  FUJIREBIO Inc. ESPLINE SARS-CoV-2 (Japan MHLW IVD - CE-IVD)

325 -  GA Generic Assays GmbH GA CoV-2 IgG/IgM/IgG+ (CE-IVD)

326 -  GenBody, Inc. GenBody COVID-19 Ag (CE-IVD)

327 -  GenBody, Inc. GenBody COVID-19 IgM/IgG (Australia TGA - Brazil ANVISA - CE-IVD)

328 -  GenBody, Inc. GenBody COVID-19 IgM/IgG 3.0 (RUO)

329 -  GenBody, Inc. GenBody FIA COVID-19 IgM/IgG (manual) (RUO)

330 -  Gencurix Inc. GenePro COVID-19 Detection Test v2 (CE-IVD)

331 -  Gencurix Inc. GenePro COVID-19 Detection Test (US FDA EUA - Philippines FDA - CE-IVD)

332 -  Gene Biosystems Gene Bio COVID-19 Qualitative Real Time PCR Kit Ver. 1.0 (RUO)

333 -  genedrive plc Genedrive®96 SARS-CoV-2 Kit (CE-IVD)

334 -  GeneFirst Ltd Respiratory Pathogen Panel (RUO)

335 -  GeneFirst Ltd The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (CE-IVD)

336 -  Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Test Kit (Hong Kong MDACS - CE-IVD)

337 -  GeneMatrix Inc. NeoPlex COVID-19 Detection Kit (US FDA EUA - India CDSCO - CE-IVD)

338 -  GeneMe Sp. z.o.o. Advanced One Step FAST Covi19 KIT Two Genes Set (CE-IVD)

339 -  GeneMe Sp. z.o.o. FRANKD (CE-IVD)

340 -  geneOmbio Technologies Pvt. Ltd geneOmbio COVID-19 rt-LAMP test (RUO)

341 -  GeneProof a.s. GeneProof SARS-CoV-2 PCR Kit (CE-IVD)

342 -  GeneProof a.s. GeneProof SARS-CoV-2 Screening PCR Kit (CE-IVD)

343 -  General Biologicals Corporation GB Viral Transport Medium (VTM) Swab Kit (CE-IVD)

344 -  General Biologicals Corporation GB SARS-CoV-2 Real Time RT-PCR (Taiwan FDA EUA - Australia TGA - India CDSCO - CE-IVD)

345 -  General Biologicals Corporation GB SARS-CoV-2 Ab ELISA (CE-IVD)

346 -  GeneReach Biotechnology Corporation POCKIT™ Central SARS-CoV-2 (orf 1ab) Premix Reagent (Taiwan FDA EUA - CE-IVD)

347 -  Generi Biotech s.r.o. gb Sarbeco E (primary test) (CE-IVD)

348 -  Generi Biotech s.r.o. gb SARS-CoV-2 N (confirmation test) (CE-IVD)

349 -  Generi Biotech s.r.o. gb SARS-CoV-2 RdRP (confirmation test) (CE-IVD)

350 -  Generi Biotech s.r.o. gb Sarbeco N (primary test) (CE-IVD)

351 -  Generi Biotech s.r.o. gb SARS-CoV-2 Multiplex (CE-IVD)

352 -  Genesystem, Co. Ltd SMARTCHEK SARS-CoV2 Detection Kit (Korea MFDS EUA - CE-IVD)

353 -  Genetic Analysis AS GA-map® COVID-19 Fecal Test (CE-IVD)

354 -  Genetic Signatures Limited EasyScreenTM Pan-Coronavirus/SARS-CoV-2 Detection Kit (Australia TGA - CE-IVD)

355 -  Genitech NSAN Pharmaceutical Pvt. Ltd COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)

356 -  GenMark Diagnostics ePlex® SARS-CoV-2 Test (US FDA EUA)

357 -  Genomax Technologies Pte Ltd Hangzhou Lysun 2019-nCoV IgG/IgM Rapid Test Device (Singapore HSA)

358 -  GenomCan Inc. Fluorescent PCR Probe Detection Kit for SARS-CoV-2 (CE-IVD)

359 -  Genomica Sau qCOVID-19 (CE-IVD)

360 -  Genomica Sau CLART COVID-19 (CE-IVD)

361 -  Genomictree, Inc. AccuraTect RT-qPCR SARS-CoV-2 (CE-IVD)

362 -  GenoSensor, LLC GS™ COVID-19 RT-PCR KIT (US FDA EUA)

363 -  GenoSUR LLC Sampling and transport device for SARS-CoV-2 and other respiratory viruses (Chile ISP)

364 -  Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) (Brazil ANVISA - Singapore HSA - CE-IVD)

365 -  GenScript 2019-nCoV qRT-PCR Detection Assay (RUO)

366 -  GenScript Biotech cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit (CE-IVD)

367 -  GENSPEED Biotech Covid-19 Complete xPOC (In development)

368 -  GENSPEED Biotech Covid-19 Ag xPOC (In development)

369 -  GENSPEED Biotech Covid-19 IgG xPOC (CE-IVD)

370 -  GenSure Biotech Inc. GenSure™ COVID-19 Antigen Rapid Kit (REF: P2004) (CE-IVD)

371 -  GenSure Biotech Inc. GenSure™ COVID-19 IgG/IgM Rapid Test (REF: P2002) (CE-IVD)

372 -  GenSure Biotech Inc. GenSure™ COVID-19 IgM Rapid Test (REF: P2001) (CE-IVD)

373 -  gerbion GmbH & Co., KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 (CE-IVD)

374 -  Getein Biotech, Inc. Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit (CE-IVD)

375 -  Getein Biotech, Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (Colloidal Gold) (India CDSCO - CE-IVD)

376 -  GFE SARS-CoV-2 PCR Reagent Kit (RUO)

377 -  GNA Biosolutions GmbH SARS-CoV-2 Detection Kit on portable PCA Analyzer (In development)

378 -  Goldsite Diagnostics Inc. SARS-CoV-2 IgG/IgM Kit (manual) (CE-IVD)

379 -  Green Cross Medical Science Corp. GENEDIA W COVID-19 Real-time RT-PCR kit (CE-IVD)

380 -  Green Cross Medical Science Corp. GENEDIA W One COVID-19 IgM/IgG (CE-IVD)

381 -  Green Cross Medical Science Corp. GENEDIA W COVID-19 Colorimetric LAMP premix kit (CE-IVD)

382 -  Green Cross Medical Science Corp. GENEDIA W COVID-19 Ag (CE-IVD)

383 -  GRiSP Xpert qDetect COVID-19 (RUO)

384 -  Guangdong Huayin Medicine Science Co,. Ltd Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) (In development)

385 -  Guangzhou Darui Biotechnology Co.,Ltd 2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) (RUO)

386 -  Guangzhou Darui Biotechnology Co.,Ltd 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) (RUO)

387 -  Guangzhou Darui Biotechnology Co.,Ltd Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold Method) (RUO)

388 -  Guangzhou Darui Biotechnology Co.,Ltd Novel Coronavirus 2019-nCoV IgG Antibody Detection Kit (Colloidal Gold Method) (RUO)

389 -  Guangzhou Fenghua Bioengineering , Co. LTD Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (RUO)

390 -  Guangzhou FulenGen Co., Ltd RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard) (In development)

391 -  Guangzhou HEAS BioTech Co., Ltd 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) (RUO)

392 -  Guangzhou Hybribio Medicine Technology Ltd Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit (In development)

393 -  Guangzhou Sagene Biotech Co., Ltd Detection Kit for novel Coronavirus (SARS-CoV-2) ORF1ab gene and N gene (RUO)

394 -  Guangzhou Supbio Biotechnologies, Inc. Supbio SARS-CoV-2 (ORF1ab/N) (Nucleic Acid Detection Kit/PCR-Fluorescent) (RUO)

395 -  Guangzhou Tebsun Bio-Tech Development Co., Ltd SARS-CoV-2 IgM/IgG Antibody Test(Colloidal Gold Immunochromatographic Assay) (CE-IVD)

396 -  Guangzhou Tebsun Bio-Tech Development Co., Ltd SARS-CoV-2 Nucleic Acid Test (LAMP) (CE-IVD)

397 -  Guangzhou Wondfo Biotech Co., Ltd Wondfo SARS-CoV-2 Nucleic Acid Detection Kit (RUO)

398 -  Guangzhou Wondfo Biotech Co., Ltd Wondfo SARS-CoV-2 Antibody Test (lateral flow method) (Singapore HSA - China NMPA EUA - Australia TGA - Brazil ANVISA - India CDSCO - CE-IVD)

399 -  Hanghzhou AllTest Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test Cassette (whole blood, serum, plasma) (Brazil ANVISA - Australia TGA - CE-IVD)

400 -  Hangzhou Bigfish Bio-tech Co., Ltd LAMP kit for qualitative detection of SARS-CoV-2 (In development)

401 -  Hangzhou Bigfish Bio-tech Co., Ltd The golden standard of SARS-CoV-2 viral nucleic acid detection (In development)

402 -  Hangzhou Biotest Biotech Co., Ltd RightSign COVID-19 IgG/IgM Rapid Test Cassette (US FDA EUA - Brazil ANVISA - Australia TGA - India CDSCO - CE-IVD)

403 -  Hangzhou Clongene Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test (Australia TGA - Brazil ANVISA - CE-IVD)

404 -  Hangzhou Dan Wei Biotechnology Co.Ltd 2019-nCoV Direct RT-qPCR Kit (In development)

405 -  Hangzhou Deangel Biological Engineering Co., Ltd Novel Coronavirus S Glycoprotein Detection Kit (Brazil ANVISA - CE-IVD)

406 -  Hangzhou Dian Biotechnology Co., Ltd Real-time RT-PCR Detection Kit For 2019-nCoV (CE-IVD)

407 -  Hangzhou Laihe Biotech Co., Ltd LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) (US FDA EUA - Australia TGA - Brazil ANVISA - CE-IVD)

408 -  Hangzhou Life Real Biotechnology Co., Ltd COVID-19 nucleic acid (RNA) POCT detection kit (AIGS real-time fluorescent PCR method) (CE-IVD)

409 -  Hangzhou Matridx Biotechnology Co., Ltd 2019-nCov Rapid Test Kit (RUO)

410 -  Hangzhou Realy Tech Co., Ltd 2019-nCOV LgG/LgM Rapid Test Device (CE-IVD)

411 -  Hangzhou Testsea Biotechnology Co., Ltd COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)

412 -  Hangzhou Testsea Biotechnology Co., Ltd New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method) (RUO)

413 -  Hecin Scientific, Inc. COVID-19 IgM Antibody Rapid Test Kit (China NMPA EUA - Brazil ANVISA - CE-IVD)

414 -  Hemcheck Sweden AB HELGE™: POC-test for rapid and objective detection of hemolysis in blood samples aimed for SARS-CoV-2 antibody testing for prevention of sample rejection in the laboratory (CE-IVD)

415 -  HiberGene Diagnostics HG Covid-19 (CE-IVD)

416 -  Hologic Inc. Panther Fusion SARS-CoV-2 assay (US FDA EUA - Health Canada - Australia TGA)

417 -  Hologic Inc. Aptima SARS-CoV-2 Assay (US FDA EUA - Australia TGA - Singapore HSA - India CDSCO - Saudi FDA)

418 -  Humasis Humasis COVID-19 IgG/IgM Test (Korea MFDS EUA - Brazil ANVISA - CE-IVD)

419 -  Hunan Lituo Biotechnology Co., Ltd COVID-19 IgG/IgM Detection Kit (Colloidal Gold) (India CDSCO - CE-IVD)

420 -  Hunan Yonghe-Sun Biotechnology Co., Ltd SARS-COV-2 specific antibody test kit (Immunochromatography) (RUO)

421 -  Huwel Lifesciences Pvt. Ltd. Quantiplus CORONA Virus (2019nCoV) detection kit (In development)

422 -  ICBFM LAMP kit for qualitative detection of SARS-CoV-2 (RUO)

423 -  ID.vet ID Screen®SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated) (CE-IVD)

424 -  Ideal Tashkhis Atieh Co. SARS-CoV-2 IgG ELISA Kit (CE-IVD)

425 -  Ideal Tashkhis Atieh Co. SARS-CoV-2 IgM ELISA Kit (CE-IVD)

426 -  IMMY clarus SARS-CoV-2 Total Antibody EIA (CE-IVD)

427 -  InBios International, Inc. InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit (US FDA EUA - RUO)

428 -  InDevR Inc. COVID Serology Kit: Multiplexed Immunoassay (RUO)

429 -  Ingenetix ViroReal® Kit SARS-CoV-2 & SARS (CE-IVD)

430 -  Innocreate Bioscience Co., Ltd Innocreate SARS-CoV-2 QD kit (Taiwan FDA EUA)

431 -  Innovita (Tangshan) Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR) (RUO)

432 -  Innovita Biological Technology Co. Ltd 2019-nCoV Antibody Test (Colloidal Gold) (China NMPA EUA - Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)

433 -  Institute of Process Engineering, Chinese Academy of Sciences Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) (In development)

434 -  Instituto de Medicina Genómica Imegen SARS-CoV-2 (CE-IVD)

435 -  Intavis Peptide Services GmbH & Co. KG Covid19-hullB CelluSpot™ Array (RUO)

436 -  InTec Products, Inc. Rapid SARS-CoV-2 Antibody (IgM/IgG) (CE-IVD)  1  2

437 -  InTec Products, Inc. Rapid SARS-CoV-2 Antibody Test (CE-IVD)  1  2

438 -  Integrated Nano Technologies Palladium System (In development)

439 -  Intrasense SA Myrian Covid-19 (China NMPA EUA - US FDA EUA - CE-IVD) PDF 2pg flyer

440 -  iNtRON Biotechnology Inc. LiliF™ COVID-19 Real-time RT-PCR Kit (In development)

441 -  IVDbio Inc. Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 (In development)

442 -  Jetta Labs LLP OZO India SARS-CoV2 (COVID-19) lgG/lgM Test (Colloidal Gold Method) (CE-IVD)

443 -  Jetta Labs LLP OZO Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (CE-IVD)

444 -  Jetta Labs LLP OZO Diamond SARS-CoV2 (COVID-19) lgG/lgM Test (Latex Method) (CE-IVD)

445 -  Jetware SRL LOMT - Pool Testing Management Software (In development)

446 -  Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (CE-IVD)

447 -  Jiangsu Bioperfectus Technologies Co. Ltd PerfectLyo SARS-COV-2 Real Time PCR kit (RUO)

448 -  Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit (CE-IVD)

449 -  Jiangsu Bioperfectus Technologies Co. Ltd PerfectQ COVID-19 Coronavirus Real Time PCR Kit (Australia TGA - US FDA EUA - WHO EUL)

450 -  Jiangsu Microdiag Biomedicine Technology Co., Ltd Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method) (RUO)  1  2

451 -  Jiangsu Microdiag Biomedicine Technology Co., Ltd Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA (RUO)  1  2

452 -  Jiangsu Qitian Gene Biotechnology Co., Ltd Fluorescent RAA Detection for 2019-nCoV (RUO)

453 -  Jiangsu Superbio Biomedical Technology (Nanjing) Co., Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (US FDA EUA - CE-IVD)

454 -  Jiangxi YeLi Medical Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) (RUO)

455 -  JinHuan Medical Instrument Co., Ltd (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (CE-IVD)

456 -  JN Medsys ProTect Covid-19 RT-qPCR kit (Singapore HSA - CE-IVD)

457 -  Joinstar Biomedical Technology Co., Ltd SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold) (CE-IVD)

458 -  JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 Neutralizing Antibody Test Kit (Lateral Flow Rapid Test) (CE-IVD)

459 -  JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)

460 -  JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (CE-IVD)

461 -  Kephera Diagnostics KDx SARS-CoV-2 IgG/IgM ELISA (In development)

462 -  Kephera Diagnostics KDx COVID-19 IgG/IgM Rapid Detection Test Kit (In development)

463 -  Kephera Diagnostics KDx Rapid SARS-CoV-2 Antigen Test (In development)

464 -  KH Medical Co. Ltd RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit (CE-IVD)

465 -  Koch Biotechnology (Beijing) Co., Ltd SARS-CoV-2 Antigen Lateral Flow Assay (MHRA UK)

466 -  KogeneBiotech Co. Ltd PowerChekTM 2019-nCoV Real-time PCR Kit (Korea MFDS EUA - CE-IVD)

467 -  Kreative Technolabs Viral RNA Extraction Kit (RUO)

468 -  KRISHGEN BioSystems Human SARS-CoV-2 (Covid-19) ELISA (RUO)

469 -  KRISHGEN BioSystems SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) (CE-IVD)

470 -  KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test (RUO)

471 -  KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) (RUO)

472 -  KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test (CE-IVD)

473 -  KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) (RUO)

474 -  KRISHGEN BioSytems Human SARS-CoV-2 (Covid-19) Qualitative ELISA (RUO)

475 -  Krosgen Biotech KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit (CE-IVD)  1  2

476 -  L&H Biotech Limited COVID-19 Antigen Rapid Test (In development)

477 -  L7 Informatics Enterprise Science Platform (HIPAA, CLIA, 21 CFR)

478 -  LabGenomics Co., Ltd LabGun™ COVID 19 Assay PCR Kit (US FDA EUA - Australia TGA - South Africa SAPHRA - CE-IVD)

479 -  Labnovation Technologies Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (CE-IVD)  1  2

480 -  Labtest Diagnostica SA Anti COVID-19 IgG/IgM Rapid Test (Brazil ANVISA)

481 -  Landcent Europe B.V. Real time RT-PCR Kit for the detection of SARS-CoV-2 (In development)

482 -  Leadgene Biomedical, Inc. Leadgene® SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit (In development)

483 -  Leadgene Biomedical, Inc. Leadgene® SARS/SARS-CoV-2 Antigen Rapid Test Kit (In development)

484 -  LG Chem Life Sciences Company AdvanSure COVID-19 real-time RT-PCR (CE-IVD)

485 -  LGC Biosearch technology Molecular assays, RNA extraction kit, rt-PCR reagents (China NMPA EUA - US FDA EUA)

486 -  Lifeassay Diagnostics Pty Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay (In development)

487 -  LifeSensors, Inc. COVID-19 IgG ELISA Detection Kit (RUO)

488 -  Liming Bio-Products Co., Ltd SrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (CE-IVD)

489 -  Liming Bio-Products Co., Ltd COVID-19 Antigen Rapid Test Device (CE-IVD)

490 -  Liming Bio-Products Co., Ltd COVID-19 IgG/IgM Combo Rapid Test Device (CE-IVD)

491 -  LOMINA AG Fast COVID19 IgM/IgG Antibody Detection Kit (Colloidal Gold) (CE-IVD)

492 -  Lumex Instruments Microchip RT-PCR COVID-19 detection system (RUO)

493 -  Luminex Corp. ARIES SARS-CoV-2 Assay (US FDA EUA - Health Canada - Singapore HSA)

494 -  Luminex Corp. NxTAG CoV Extended Panel (US FDA EUA - Health Canada)

495 -  Luminostics, Inc. CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) (In development)

496 -  LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgM EIA Test (CE-IVD)

497 -  LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG EIA Test (CE-IVD)

498 -  LumiQuick Diagnostics Inc. QuickProfile™ COVID-19 ANTIGEN Test (Brazil ANVISA - Philippines FDA - CE-IVD)

499 -  LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG/IgM Combo Test Card (Brazil ANVISA - CE-IVD)

500 -  LumiQuick Diagnostics Inc. Quicknostics® COVID-19 RT-PCR (Brazil ANVISA - CE-IVD)

501 -  M monitor Inc. Isopollo COVID-19 detection Kit (real-time) (CE-IVD)

502 -  Mabsky Bio-Tech Co., Ltd Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit (CE-IVD)

503 -  Mabsky Bio-Tech Co., Ltd COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method) (CE-IVD)

504 -  Mabsky Bio-Tech Co., Ltd COVID-19 virus (2019-nCoV) Dual-Detection Kit (CE-IVD)

505 -  Maccura Biotechnology Co., Ltd SARS-CoV-2 Nucleic Detection Kit (Fluorescent PCR) (China NMPA EUA - US FDA EUA - CE-IVD)

506 -  Mammoth Biosciences SARS-CoV-2 DETECTR (In development)

507 -  Medical & Biological Laboratories Co., Ltd MEBRIGHT™ SARS-CoV-2 Kit (Japan MHLW IVD - CE-IVD)

508 -  Medical Innovation Ventures Sdn Bhd. GenoAmp® Real-Time RT-PCR SARS-CoV-2 (CE-IVD)

509 -  Medical System Coronavirus PCR test (China NMPA EUA - CE-IVD)

510 -  MedicalSystem Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Cassette (CE-IVD)

511 -  Mediclone Biotech Pvt Ltd @sight COVID-19 IgG/IgM Rapid Test Kit (In development)

512 -  Medigen Vaccine Biologics Corp. MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit (CE-IVD)  1  2

513 -  Medigen Vaccine Biologics Corp. MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit (RUO)  1  2

514 -  Medisys International SA Gmate Covid-19 (CE-IVD)

515 -  Medsource Ozone Biomedicals COVID 19 IgG IgM Rapid Test (India CDSCO)

516 -  MedStar Medical Co., Ltd One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus (In development)

517 -  Meril Diagnostics Pvt Ltd Meril COVID-19 One-step RT-PCR Kit (India CDSCO)

518 -  MGI Tech Co., Ltd Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation (In development)

519 -  MiCo Biomed Co. Ltd VERI-QTM PCR 316 COVID-19 detection system (Brazil ANVISA - Philippines FDA - RUO)

520 -  MicroDigital Co., Ltd MDGen AB96-COVID-19 IgG (CE-IVD)

521 -  Mikrogen GmbH ampliCube Coronavirus Panel (CE-IVD)

522 -  Mikrogen GmbH ampliCube Coronavirus SARS-CoV-2 (CE-IVD)

523 -  Mikrogen GmbH recomWell SARS-CoV-2 IgG (CE-IVD)

524 -  Mikrogen GmbH recomWell SARS-CoV-2 IgA (CE-IVD)

525 -  Mikrogen GmbH recomLine SARS-CoV-2 IgG (CE-IVD)

526 -  Mobidiag Amplidiag COVID-19 (CE-IVD)

527 -  Mobidiag Novodiag COVID-19 (CE-IVD)

528 -  Mobidiag Novodiag® COVID-19 + InfA/B (lab-based & near-POC) (In development)

529 -  Module Innovations Private Ltd nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) (In development)

530 -  Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay (CE-IVD)  1  2

531 -  Molbio Diagnostics Pvt Ltd Truenat SARS CoV-2 (lab-based or near-POC) (India CDSCO)

532 -  MolDiag by MAScIR MAScIR-SARS-CoV-2 PCR Kit (Morocco DMP-IVD - CE-IVD)

533 -  Mologic Ltd SARS-CoV-2 Triple RDT (IgA/IgG/IgM) (RUO)

534 -  Mologic Ltd Mologic COVID-19 Rapid Test (In development)

535 -  Mologic Ltd SARS-CoV-2 ELISA Serology (RUO)

536 -  MP Biomedicals ASSURE SARS-CoV-2 IgG/IgM Rapid Test (Singapore HSA - CE-IVD)

537 -  MP Biomedicals MP Rapid 2019-nCoV IgG/IgM (CE-IVD)

538 -  Multi-G B.V. COVID-19 IgG/IgM Ab Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)

539 -  Mylab Discovery Solutions Pvt Ltd PathoDetect CoVID-19 Detection Kit (India CDSCO)

540 -  myPOLS Biotec GmbH Direct SARS-CoV-2 PCR detection kit w/o extraction (In development)

541 -  nal von minden GmbH NADAL® COVID-19 IgG/IgM Test (243003N-25, 243002N-20, 243001N-10) (CE-IVD)

542 -  Nanjing BioPoint Diagnostics BioPoint SARS-CoV-2 dIgA/total antibody rapid test (In development)

543 -  Nanjing Vazyme Medical Technology Co., Ltd 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit (China NMPA EUA - CE-IVD)

544 -  Nanjing Vazyme Medical Technology Co., Ltd 2019-Novel Coronavirus (2019-nCoV) IgG/IgM Detection Kit (China NMPA EUA - Brazil ANVISA - CE-IVD)

545 -  Nanjing Weiyun Biotechnology Co., Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (CE-IVD)

546 -  Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test (CE-IVD)

547 -  NanoBio Lab, A*STAR Research Entities Isothermal Exponential Amplification for COVID-19 Detection (RUO)

548 -  NanoEntek Inc. FREND™ COVID-19 IgG/IgM Duo (Korea MFDS EUA - CE-IVD)

549 -  NanoEntek Inc. En-swer COVID-19 RT-PCR Kit (Korea export - CE-IVD)

550 -  Nantong Egens Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (Australia TGA - Brazil ANVISA - CE-IVD)

551 -  National Institute for Control of Vaccines and Biologicals Accupid nCoV 2019 Detection Kit (RUO)

552 -  NDFOS Co., Ltd ND COVID-19 Detection Kit (Korea MFDS EUA - CE-IVD)

553 -  NDFOS Co., Ltd ND COVID-19 IgG/IgM Rapid Test (Korea MFDS EUA - CE-IVD)

554 -  Neomedica d.o.o. NAISSA SARS COV-2 IgA/IgM/IgG (CE-IVD)

555 -  Next Pharma Inc. DiaCarta's QuantiVirus™SARS-CoV-2 Test (US FDA EUA - CE-IVD)

556 -  NG Biotech NG-Test IgG-IgM COVID-19 (CE-IVD)

557 -  Ningbo Health Gene Technologies Co. Ltd. SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) (RUO - WHO EUL)

558 -  Nirmidas Biotech, Inc. pGOLD COVID-19 IgG/IgM/IgA Microarray Test (RUO)

559 -  Nirmidas Biotech, Inc. Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit (RUO)

560 -  Norgen Biotek Corp Saliva RNA Collection and Preservation Devices RU53800 (RUO)

561 -  Norgen Biotek Corp 2019-nCoV TaqMan RT-PCR Kit (RUO)

562 -  Norgen Biotek Corp Swab Collection and Total Nucleic Acid Preservation System (68800) (RUO)

563 -  Norgen Biotek Corp Total RNA Purification Kit Dx (Dx17200) (CE-IVD)

564 -  NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgA (CE-IVD)

565 -  NovaTec Immundiagnostica GmbH GSD NovaPrime® SARS-CoV-2 (COVID-19) (CE-IVD)

566 -  NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgG (CE-IVD)

567 -  NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgM (CE-IVD)

568 -  NTBio Diagnostics Inc. COVID-19 IgG/IgM Antibody Test Cassette (Australia TGA - CE-IVD)

569 -  NZYTech NZY Viral RNA Isolation kit (RUO)

570 -  NZYTech SARS-CoV-2 One-Step RT-PCR Kit, CE-IVD (MD03201) (CE-IVD)

571 -  NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RUO (MD03191) (RUO)

572 -  OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT-PCR Test (US FDA EUA - CE-IVD)

573 -  Optolane Technologies Inc. Kaira 2019-nCoV Detection kit (CE-IVD)

574 -  Optolane Technologies Inc. Dr. PCR COVID-19 Viral Load 20K (lab-based) (RUO)

575 -  Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total (US FDA EUA - Singapore HSA - Australia TGA)

576 -  Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG (US FDA EUA)

577 -  OsangHealthcare GeneFinder COVID-19 Plus RealAmp Kit (Health Canada - Brazil ANVISA - Singapore HSA - CE-IVD)

578 -  Pantest SA Pantest Coronavirus IgM/IgG (CE-IVD)

579 -  Paragon Genomics Inc. CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel (RUO)

580 -  PathoFinder RealAccurate Quadruplex Corona-plus PCR Kit (CE-IVD)

581 -  PathoFinder RealAccurate Quadruplex SARS-CoV2 PCR Kit (CE-IVD)

582 -  PaxGen Bio Co. Ltd PaxView COVID-19 real time RT-PCR (CE-IVD)

583 -  PCL Inc. PCL COVID19 Ag Rapid FIA (CE-IVD)

584 -  PCL Inc. PCL COVID19 IgG/IgM Rapid Gold (Korea MFDS EUA - Australia TGA - CE-IVD)

585 -  PCL Inc. PCLMD™ nCoV one step RT-PCR Kit (Korea MFDS EUA - Health Canada - Singapore HSA - South Africa SAHPRA - Brazil ANVISA - CE-IVD)

586 -  PEPperPRINT GmbH PEPperCHIP® SARS-CoV-2 Proteome Microarray (manual) (CE-IVD)

587 -  PerGrande BioTech Development Co., Ltd SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) (CE-IVD)

588 -  PerkinElmer Inc. PerkinElmer® SARS-CoV-2 Realtime RT-PCR Assay (US FDA EUA - Health Canada - Singapore HSA - South Africa SAHPRA - Philippines FDA - CE-IVD - WHO EUL)

589 -  PharmAct AG SARS COVID-19 Rapid Test (CE-IVD)  1  2

590 -  Pharmaline Saglik Hizmetleri Ticaret A.S. LAMPIGEN COVID-19 RT LAMP Kit (Turkey MoH - CE-IVD)

591 -  Pharmaline Saglik Hizmetleri Ticaret A.S. COVIDIGEN Multiplex COVID-19 qRT-PCR KIT (Turkey MoH - CE-IVD)

592 -  Pinpoint Science Inc. Pinpoint Covid-19 Screening Assay (In development)

593 -  Pishtaz Teb Diagnostics SARS-CoV-2 IgG ELISA Kit (CE-IVD)

594 -  Pishtaz Teb Diagnostics SARS-CoV-2 IgM ELISA Kit (CE-IVD)

595 -  Pishtaz Teb Diagnostics COVID-19 One-Step COVID-19 RT-PCR Kit (CE-IVD)

596 -  PlexBio Co., Ltd PlexBio CoVid19/SARS/Influenza A, B Detection kit (In development)

597 -  Prantae Solutions Pte Ltd EyeRa-Covid (In development)

598 -  PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (US FDA EUA - CE-IVD)

599 -  Precision Biosensor, Inc. Exdia COVID-19 IgG/IgM (CE-IVD)

600 -  Precision Biosensor, Inc. PBCheck COVID-19 IgG/IgM (CE-IVD)

601 -  Predigen Inc. HR-PreV (In development)

602 -  Premier Medical Corporation Pvt. Ltd SureStatus COVID-19 (SARS-CoV-2) EIA Test (In development)

603 -  Premier Medical Corporation Pvt. Ltd SureStatus COVID-19 (SARS-CoV-2) Card Test (In development)

604 -  PRIMA Lab S.A. PRIMA COVID-19 IgG/IgM Rapid Test (CE-IVD)

605 -  PRIME4DIA Co., Ltd P4DETECT COVID-19 SAg (RUO)

606 -  PRIME4DIA Co., Ltd P4DETECT COVID-19 IgM/IgG (CE-IVD)

607 -  PRIME4DIA Co., Ltd P4DETECT COVID-19 Ag (RUO)

608 -  Primerdesign Ltd genesig Real-Time PCR COVID-19 (US FDA EUA - CE-IVD - WHO EUL)

609 -  PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19) Test (US FDA EUA)

610 -  Progenie Molecular S.L.U. RealCycler CORO (CE-IVD)

611 -  Prognosis Biotech Bio-Shield 2019-nCoV Total Immunoglobulins (IgA, IgG, IgM) (RUO)

612 -  Prognosis Biotech Bio-Shield 2019-nCoV IgM (RUO)

613 -  Prognosis Biotech Bio-Shield 2019-nCoV IgG (RUO)

614 -  Prognosis Biotech Rapid test 2019-nCoV Total Ig Immunoglobulins (IgA, IgG, IgM) (RUO)

615 -  Prognosis Biotech Rapid test 2019-nCoV IgM/IgG (RUO)

616 -  Prometheus Bio Inc. 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) (CE-IVD)

617 -  Promis Diagnostics SensDtect RT-qPCR SARS CoV-2 (RUO)

618 -  ProteomeTech Inc. GENEdania COVID-19 qRT-PCR (CE-IVD)

619 -  ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM (CE-IVD)

620 -  QIAGEN GmbH QIAstat-Dx Respiratory Panel 2019-nCoV (US FDA EUA - Australia TGA - Health Canada - Singapore HSA - Philippines FDA - CE-IVD)  1  2

621 -  Qingdao Funuo Biomedical Co., Ltd COVID-19 Multiplex Fluorescent PCR Kit (CE-IVD)

622 -  Qingdao Hightop Biotech Co., Ltd Hightop COVID-19 IgM/IgG Ab Rapid Test Kit (Australia TGA - Brazil ANVISA - CE-IVD)

623 -  Qingdao Jianma Gene Technology Co., Ltd. COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) (RUO)

624 -  Quadratech Diagnostics Ltd COVID-19-CHECK-1 (CE-IVD)

625 -  Quansys Biosciences SARS-CoV-2 Human IgG (4-Plex) (In development)

626 -  QuantuMDx QPOC™ Point of Care NAT for SARS-CoV-2 (In development)  1  2

627 -  QuantuMDx QuantuMDx NAT for SARS-CoV-2 (CE-IVD)  1  2

628 -  Quick Energy Technologies Limited MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) (CE-IVD)

629 -  Quidel Lyra SARS-CoV-2 Assay (US FDA EUA - Health Canada - CE-IVD)

630 -  Quidel Sofia 2 SARS Antigen FIA (US FDA EUA)

631 -  QuikPath Pte Ltd QuikPath Covid-19 POC molecular test (In development)

632 -  Quotient Limited SA MosaiQ™ COVID-19 Antibody Microarray (CE-IVD)

633 -  R-Biopharm AG RIDA® GENE SARS-CoV-2 RUO (PG6815RUO) (CE-IVD)

634 -  RainSure Scientific Co., Ltd RainSure COVID-19 dPCR Detection Kit (lab-based) (RUO)

635 -  Randox Laboratories Ltd Extended Coronavirus Array (lab-based or near-POC) (RUO)

636 -  Rapid Bio LLC Rapid test for IgM/IgG antibodies against SARS-COV-2 (RUO)

637 -  RapiGEN Inc. BIOCREDIT COVID-19 Ag (Brazil ANVISA - Philippines FDA - CE-IVD)

638 -  RapiGEN Inc. BIOCREDIT COVID-19 IgG+IgM Duo (CE-IVD)

639 -  RapiGEN Inc. BIOCREDIT COVID-19 IgG (RUO)

640 -  RayBiotech Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) (CE-IVD)

641 -  Redcliffe Bioscience Redcliffe Bioscience LightPower iVA-SARS-COV-2 One Step RT-rPCR KIT (Vietnam MoH - CE-IVD)  1  2

642 -  Redcliffe Bioscience SARS – CoV2 lgG ELISA SARS & CoV2 lgM ELISA (µ-Capture) (CE-IVD)  1  2

643 -  RetroVirox Inc. SARS-CoV-2 Pseudovirus assay for Neutralizing Antibodies (RUO)

644 -  Rheonix, Inc. Rheonix COVID-19 MDx Assay (US FDA EUA - Australia TGA - Singapore HSA)

645 -  Ring Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Kit (CE-IVD)

646 -  Roche Elecsys Anti-SARS-CoV-2 (US FDA EUA - Australia TGA - Health Canada - Brazil ANVISA - Singapore HSA - South Africa SAHPRA - CE-IVD)

647 -  Roche Molecular Diagnostics cobas® SARS-CoV-2 (for use on the cobas® 6800/8800 Systems) (US FDA EUA - Health Canada - Brazil ANVISA - Australia TGA - Singapore HSA - South Africa SAHPRA - WHO EUL)

648 -  RPC Diagnostic Systems Anti-SARS-CoV-2 Enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19) (CE-IVD)

649 -  RPC Diagnostic Systems DS-?IA-Anti-SARS-CoV-2-G Enzyme immunoassay for the detection of IgG - antibodies to SARS-CoV-2 (COVID-19) (CE-IVD)

650 -  Sacace Biotechnologies SARS-CoV-2 Real-TM (CE-IVD)

651 -  Saladax Biomedical Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (CE-IVD)

652 -  Sansure Biotech, Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (US FDA EUA - China NMPA EUA - Singapore HSA - Australia TGA - South Africa SAHRPA - CE-IVD)

653 -  ScheBo Biotech AG ScheBo SARS-CoV-2 Quick (US FDA EUA - India CDSCO - Brazil ANVISA - CE-IVD)

654 -  Schweitzer Biotech Company Ltd SBC RNP qPCR Kit (RUO)

655 -  Schweitzer Biotech Company Ltd SBC SARS-CoV-2 qPCR Kit (CE-IVD)

656 -  Schweitzer Biotech Company Ltd SBC SARS-CoV-2 Convective PCR Diagnostic Device/Kit (RUO)

657 -  Scope Fluidics SA PCR|COV (In development)  1  2

658 -  SD BIOSENSOR Inc. STANDARD M nCoV Real-Time Detection Kit (US FDA EUA - Korea MFDS EUA - Brazil ANVISA - Philippines FDA - CE-IVD)

659 -  SD BIOSENSOR, Inc. STANDARD Q COVID-19 Ag Test (Brazil ANVISA - CE-IVD)

660 -  SD BIOSENSOR, Inc. STANDARD F COVID-19 Ag FIA (Brazil ANVISA - CE-IVD)

661 -  SD BIOSENSOR, Inc. STANDARD E COVID-19 Total Antibody Test (RUO)

662 -  SD BIOSENSOR, Inc. STANDARD Q COVID-19 IgM/IgG Duo Test (Brazil ANVISA - CE-IVD)

663 -  SEASUN BIOMATERIALS U-TOP™ COVID-19 Detection Kit (US FDA EUA - Korea MFDS EUA - Singapore HSA - China NMPA EUA - CE-IVD)

664 -  SEASUN BIOMATERIALS AQ-TOP™ COVID-19 Rapid Detection Kit (US FDA EUA - CE-IVD)  1  2

665 -  Seegene, Inc. Allplex 2019-nCoV assay (US FDA EUA - Health Canada - Australia TGA - Korea MFDS EUA - Singapore HSA - South Africa SAHPRA - Brazil ANVISA - CE-IVD)

666 -  Selfdiagnostics Deutschland GmbH Multitest (In development)

667 -  Sengenics Corporation Pte Ltd ImmuSAFE™ COVID Protein Microarray (RUO)

668 -  Sengenics Corporation Pte Ltd ImmuSAFE™ COVID+ Protein Microarray (RUO)

669 -  Sengenics Corporation Pte Ltd ImmuSAFE™ Respiratory Virus Protein Microarray (RUO)

670 -  SensingSelf, Pte, Ltd, Singapore COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) (India CDSCO - CE-IVD)

671 -  Sente Biolab Senteligo Covid-19 qRT PCR Detection Kit (CE-IVD)

672 -  Sentinel CH STAT-NAT® Covid-19 HK and STAT-NAT® Covid-19 B (Philippines FDA - CE-IVD)

673 -  servoprax GmbH Cleartest Corona, Covid-19 (CE-IVD)  1  2

674 -  Shaanxi Lifegen Co., Ltd Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) (CE-IVD)

675 -  Shandong Shtars Biological Industry Co., Ltd Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual (RUO)

676 -  Shandong ThinkLab Biotechnology Co., Ltd 2019-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) (CE-IVD)

677 -  Shanghai Chemtron Biotech Co. Ltd 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) (CE-IVD)

678 -  Shanghai Fosun Long March Medical Science Co., Ltd Fosun Novel Coronavirus (2019-nCoV) IgG/IgM rapid test kit (Immunofluorescence) (Brazil ANVISA - CE-IVD)

679 -  Shanghai Fosun Long March Medical Science Co., Ltd Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (US FDA EUA - Australia TGA - Brazil ANVISA - China NMPA EUA - Singapore HSA - CE-IVD - WHO EUL)

680 -  Shanghai GeneoDx Biotechnology Co., Ltd Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) (China NMPA EUA - WHO EUL)

681 -  Shanghai Igenetec Diagnostics Co., Ltd Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) (RUO)  1  2

682 -  Shanghai Kehua Bio-engineering Co., Ltd SARS-CoV-2 Nucleic Acid Test (RUO)

683 -  Shanghai Kehua Bio-engineering Co., Ltd Diagnostic kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) (CE-IVD)

684 -  Shanghai LiangRun Biomedicine Technology Co. Ltd Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2 (Collodial Gold /Lateral Flow) (Brazil ANVISA - Singapore HSA - CE-IVD)

685 -  Shanghai Outdo Biotech Co., Ltd Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold) (China NMPA EUA - Brazil ANVISA - CE-IVD)

686 -  Shanghai Rendu Biotechnology Co., Ltd AmpSure 2019-nCov RNA Assay (RUO)

687 -  Shanghai ZJ Bio-Tech Co., Ltd/Liferiver Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit (China NMPA EUA - Australia TGA - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)  1  2

688 -  ShanXi Medical University SARS-COV-2 IgM/IgG antibody test (Colloidal Gold) (RUO)

689 -  Shenzhen Bioeasy Biotechnology Co., Ltd WITHDRAWN – Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test

690 -  Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Total Ab GICA Rapid Test (CE-IVD)

691 -  Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) (CE-IVD)

692 -  Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ab (IgG/IgM) GICA Rapid Test Kit (Gold Colloidal Immunoassay) (CE-IVD)

693 -  Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 Nucleic Acid Test Kit (RT-PCR) (CE-IVD)

694 -  Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold) (CE-IVD)

695 -  Shenzhen LeafMed Technology Ltd Coronavirus COVID-19(SARS-CoV-2) IgM/IgG Rapid Test Kit (CE-IVD)

696 -  Shenzhen Lvshiyuan Biotechnology Co., Ltd Greenspring® COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit (CE-IVD)

697 -  Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) (CE-IVD)  1  2

698 -  Shenzhen Mindray Bio-Medical Electronics Co., Ltd Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA) (CE-IVD)

699 -  Shenzhen Mindray Bio-Medical Electronics Co., Ltd Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) (CE-IVD)

700 -  Shenzhen Puruikang Biotech Co., Ltd Detection Kit for 2019-Novel Coronavirus RNA (RT-PCR-Fluorescence Probing) (CE-IVD)

701 -  Shenzhen Render Bio-tech Co., Ltd. COVID-19 IgM & IgG Test (Immunochromatography) (CE-IVD)

702 -  Shenzhen Shineway Technology Corp. SARS-CoV-02 PCR Testing Kit (RUO)

703 -  Shenzhen Tailored Medical Ltd New Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (CE-IVD)

704 -  Shenzhen Tailored Medical Ltd Novel Coronavirus (SARS-CoV-2) IgM/IgG Antibody Assay Kit (Colloidal Gold Method) (CE-IVD)

705 -  Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgM (CE-IVD)

706 -  Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgG (CE-IVD)

707 -  Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgM/IgG (CE-IVD)

708 -  Shenzhen Zhenrui Biotech Co., Ltd COVID-19 IgGg/IgM Rapid Test Cassette (WB/S/P) (CE-IVD)

709 -  Sherlock Biosciences Sherlock™ CRISPR SARS-CoV-2 (In development)

710 -  Shimadzu Corp. 2019 Novel Coronavirus Detection Kit (RUO)

711 -  Sichuan Xincheng Biological Co., Ltd SARS-Cov-2 IgG/M Antibody Assay Kit by Immunofluorescence Chromatography Method (CE-IVD)

712 -  Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 Total (COV2T) (US FDA EUA)

713 -  Siemens Healthineers Atellica®IM SARS-CoV-2 Total (COV2T) (US FDA EUA - Canada Health - Australia TGA - Singapore HAS - CE-IVD)

714 -  SignalDT Biotechnologies (SZ), Inc. LyoDx® A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 (In development)

715 -  SLS Bio Co. Ltd SsmarTest COVID-19 IgM/IgG Detection Kit (Korea MFDS EUA - CE-IVD)

716 -  Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI 2019-nCoV IgG (CLIA) (Brazil ANVISA - CE-IVD)

717 -  Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI 2019-nCoV IgM (CLIA) (Brazil ANVISA - CE-IVD)

718 -  SNP Biotechnology R&D Ltd Co. COVID-19 Real Time PCR Kit (CE-IVD)

719 -  Solgent Co.Ltd DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit (Korea MFDS EUA - US FDA EUA - Philippines FDA - Singapore HSA - CE-IVD)

720 -  Sona Nanotech Sona-COVID-19 LFA (In development)

721 -  Spectrum for Diagnostic Industries (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit (RUO)

722 -  Spindiag GmbH Spindiag Rhonda SARS-CoV-2 test (In development)

723 -  Spring Healthcare Services AG COVID-19 IgG/IgM Rapid Test (colloidal gold-based) (CE-IVD)

724 -  St. Petersburg Research Institute of Vaccines and Sera (FSUE SPbSRIVS FMBA) SARS-CoV-2 Tru-EIA (RUO)

725 -  Star Array Pte Ltd 8-minute RT-qPCR direct PCR testing system for SARS-CoV-2 detection (RUO)

726 -  STILLA COVID-19 Multiplex Crystal Digital PCR detection kit (In development)

727 -  Sugentech, Inc. SGTi-flex COVID-19 IgM (RDT) (CE-IVD)

728 -  Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (RDT) (CE-IVD)

729 -  Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (manual) (CE-IVD)

730 -  Sugentech, Inc. SGTi-flex COVID-19 IgM (manual) (CE-IVD)

731 -  Sugentech, Inc. SGTi-flex COVID-19 IgG (RDT) (CE-IVD)

732 -  Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM/IgG Ab Rapid Test (CE-IVD)

733 -  Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgG Ab Rapid Test (CE-IVD)

734 -  Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM Ab Rapid Test (CE-IVD)

735 -  Suzhou BTA Biotech Co. Ltd Real time RT-PCR Kit for the detection of SARS-CoV-2 (China NMPA EUA)

736 -  Syrona Limited COVID-19 IgG/IgM Rapid Test Cassette (CE-IVD)

737 -  Systaaq Diagnostic Products 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit (CE-IVD)

738 -  Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgG (CE-IVD)

739 -  Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgM (CE-IVD)

740 -  TargetingOne Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Digital PCR method) (RUO)

741 -  Tauschen Int. Ltd (Tauschen Groups) COVID - 19 RAPID TEST KIT / Antibody IgG& IgM Test Kit (China NMPA EUA - CE-IVD)

742 -  TECOmedical AG / Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019-nCOV IgM Antibody kit (ELISA) (Philippines FDA - CE-IVD)

743 -  TECOmedical AG / Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019-nCOV IgG Antibody kit (ELISA) (Philippines FDA - CE-IVD)

744 -  Telepoint Medical Services LLC Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test (RUO)

745 -  Tellgen Corporation SARS-CoV-2 Nucleic acids detection kit based on Real-Time PCR platform (CE-IVD - WHO EUL)

746 -  TestLine Clinical Diagnostics Ltd EIA COVID-19 NP IgA / EIA COVID-19 NP IgM / EIA COVID-19 NP IgG (CE-IVD)

747 -  TestLine Clinical Diagnostics Ltd Microblot-Array COVID-19 IgA / Microblot-Array COVID-19 IgG / Microblot-Array COVID-19 IgM (CE-IVD)

748 -  TestLine Clinical Diagnostics Ltd SmartEIA COVID-19 NP IgA / SmartEIA COVID-19 NP IgG / SmartEIA COVID-19 NP IgM (CE-IVD)

749 -  Tetracore Inc. Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) (RUO)

750 -  Tezted Oy SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily) (CE-IVD)

751 -  Thermo Fisher Scientific TaqPath™ COVID-19 CE-IVD RT-PCR Kit (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)

752 -  Thermo Fisher Scientific TaqPath™ COVID-19 Combo Kit (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - South Africa SAHPRA)

753 -  Tianjin Era Biology Technology Co., Ltd COVID-19 IgM/IgG Lateral Flow Assay (CE-IVD)

754 -  Tianjin Era Biology Technology Co., Ltd COVID-19 IgM Lateral Flow Assay (CE-IVD)

755 -  Tianjin Era Biology Technology Co., Ltd COVID-19 IgG Lateral Flow Assay (CE-IVD)

756 -  Tianjin Jianbo Biological Co., Ltd SARS-CoV-2 Specific IgM and IgG Test Kit (Coillodal Gold) (RUO)

757 -  Tianjin MNCHIP Technologies Co., Ltd. Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) (CE-IVD)

758 -  TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19 RdRP-gene (RUO)

759 -  TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19) N-gene (RUO)

760 -  TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19) E-gene (RUO)

761 -  TransGen Biotech Co., Ltd SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR) (CE-IVD)

762 -  Trax Management Services Inc. PhoenixDx 2019-CoV (US FDA EUA - Philippines FDA)

763 -  Trinity Biotech Bartels FlexTrans™ Medium (US FDA EUA)

764 -  Trivitron Healthcare Pvt. Ltd RNAsure RNA Extraction Kit (CE-IVD)

765 -  Trivitron Healthcare Pvt. Ltd ViSure transport kit (CE-IVD)

766 -  Trivitron Healthcare Pvt. Ltd NATSure COVID-19 SinglePlex Real-time PCR Kit (CE-IVD)

767 -  Twist Bioscience NGS-based target capture for SARS-CoV-2 detection and screening (In development)

768 -  U2USystems (India) Pvt. Ltd 2019-ncoV IgG/IgM Test (CE-IVD)

769 -  Ukrgentech RT-PCR test kit for COVID-19 detection (CE-IVD)

770 -  Ultrabio Technologies Inc. SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (RUO)

771 -  University of Washington Tongue swab diagnosis of SARS-CoV-2 (In development)

772 -  Ustar Biotechnologies (Hangzhou) Ltd EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA (Australia TGA - China NMPA EUA)

773 -  Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test (US FDA EUA - Singapore HSA - Philippines FDA - CE-IVD)

774 -  Veredus Laboratories Pte Ltd VereRTCoV™ SARS-CoV-2 Real-Time RT-PCR 2.0 (Singapore HSA - Philippines FDA)

775 -  Veredus Laboratories Pte Ltd VereCoV™ Detection Kit and VerePLEX™ Biosystem (Singapore HSA - CE-IVD)

776 -  Veredus Pte Ltd LIONRUN Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 (China NMPA EUA - Singapore HSA)

777 -  Verify Diagnostics Inc. Covid-19 IgG/IgM Antibody Rapid Test (RUO)

778 -  Viet A Technology Corporation LightPower iVASARS-CoV-2 1st RT-rPCR Kit (CE-IVD)

779 -  Vircell S.L. COVID-19 VIRCLIA® IgG MONOTEST (CE-IVD)

780 -  Vircell S.L. COVID-19 VIRCLIA® IgM+IgA MONOTEST (CE-IVD)

781 -  Vircell S.L. COVID-19 ELISA IgM+IgA (CE-IVD)

782 -  Vircell S.L. COVID-19 ELISA IgG (CE-IVD)

783 -  Vircell, S.L. SARS-COV-2 REALTIME PCR KIT (Brazil ANVISA - CE-IVD)

784 -  Visible Patient Visible Patient Service - numerical (medical image analysis, CT or MRI) (US FDA 501(k) - CE Class IIa)

785 -  Vision Biotechnology Research & Development VISION COVID19 Easyprep Test Kit (In development)

786 -  Vitassay Healthcare S.L. Vitassay qPCR SARS-CoV-2 (CE-IVD) Test description in Spanish

787 -  Vitro SA SARS-CoV-2 RT-PCR (CE-IVD)

788 -  VivaChek Biotech (Hangzhou) Co., Ltd VivaDiag COVID-19 IgM/IgG Rapid Test (Australia TGA - India CDSCO - Singapore HSA - CE-IVD)

789 -  Wells Bio, Inc. careGENE™ COVID-19 RT-PCR kit (Korea MFDS EUA - CE-IVD)

790 -  Wells Bio, Inc. careGENE™ N-CoV RT-PCR kit (Korea MFDS EUA - Brazil ANVISA - CE-IVD)

791 -  Wells Bio, Inc. careUS™ COVID-19 IgM/IgG (In development)

792 -  WESAIL Biotech Inc. WESAIL COVID-19 IgM IgG Antibody Test Kit (CE-IVD)

793 -  Willi Fox GmbH Willi Fox Covid-19 IgM/ IgG rapid test (CE-IVD)

794 -  Wizbiosolutions Inc. WizDx™ COVID-19 Real-time PCR Kit (Korea MFDS EUA - CE-IVD)

795 -  Wizbiosolutions Inc. WizDx™ COVID-19 CrystalMix PCR Kit (Korea MFDS EUA - CE-IVD)

796 -  Wuhan EasyDiagnosis Biomedicine Co., Ltd Novel Coronavirus IgG antibody test kit (colloidal gold method) (Australia TGA - Brazil ANVISA - CE-IVD)

797 -  Wuhan Easydiagnosis Biomedicine Co., Ltd COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit (China NMPA EUA - Australia TGA - South Africa SAHPRA - Philippines FDA - CE-IVD)

798 -  Wuhan EasyDiagnosis Biomedicine Co., Ltd Novel Coronavirus IgM antibody test kit (colloidal gold method) (Australia TGA - Brazil ANVISA - CE-IVD)

799 -  Wuhan HealthCare Biotechnology Co., Ltd Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit (CE-IVD)

800 -  Wuhan UNscience Biotechnology Co., Ltd Covid-19 IgG/IgM Antibody Rapid Test Kit (Brazil ANVISA - CE-IVD)

801 -  Wuxi Shenrui Bio-pharmaceuticals Co. Ltd Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection (In development)

802 -  Xi'an Goldmag Nanobio Tech Co., Ltd Real-Time RT-PCR assays for the detection of SARS-CoV-2 (CE-IVD)

803 -  Xiamen Biotime Biotechnology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit (US FDA EUA - CE-IVD)

804 -  Xiamen Boson Biotech Co. Ltd Rapid 2019-nCoV IgG/IgM Combo Test Card (Singapore HSA - CE-IVD)

805 -  Xiamen Wiz Biotech Co. Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 (CE-IVD)

806 -  Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR) (US FDA EUA - CE-IVD)  1  2

807 -  Xi’an Tianlong Science and Technology Co., Ltd COVID-19 ORF1ab/N Gene PCR Detection Kit (RUO)

808 -  Yaneng BIOscience (Shenzhen) Co., Ltd COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR) (RUO)

809 -  YD Diagnostics Corp. MolecuTech® Real-Time COVID-19 (CE-IVD)

810 -  YouSeq Ltd YouSeq SARS-COV-2 qPCR Test (RUO)

811 -  Yuno Diagnostics Co., Ltd Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits (CE-IVD)

812 -  Zalgen Labs, LLC ReSARS Pan-Corona Antigen ELISA Kit (In development)

813 -  Zalgen Labs, LLC ReSARS Pan-Corona IgM ELISA Kit (In development)

814 -  Zalgen Labs, LLC ReSARS CoV-2 IgM ELISA Kit (In development)

815 -  Zalgen Labs, LLC ReSARS CoV-2 Antigen Rapid Test (In development)

816 -  Zalgen Labs, LLC ReSARS Pan-Corona Rapid Test (In development)

817 -  Zalgen Labs, LLC ReSARS CoV-2 Antigen ELISA Kit (In development)

818 -  Zentech SA QuickZen COVID-19 IgM / IgG (RUO)  1  2

819 -  Zephyr Biomedicals-Tulip Group COVISCREEN–Rapid double antigen screening test for detection of IgM/IgG/IgA antibodies to COVID-19 in human serum/plasma/whole blood (India CDSCO - CE-IVD)  1  2

820 -  Zhejiang Gene Science Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (CE-IVD)

821 -  Zhejiang Orient Gene Biotech COVID-19 IgG/IgM Rapid Test (Australia TGA - CE-IVD)

822 -  Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgG ELISA test (CE-IVD)

823 -  Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgM ELISA test (CE-IVD)

824 -  Zhuhai Haitai Biological Pharmaceutical Co., Ltd Novel Coronavirus (2019-nCoV)/Flu A/Flu B Real-time Multiplex RT-PCR Kit (manual & automated lab-based) (RUO)

825 -  Zhuhai Livzon Diagnostics Inc. Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) (RUO)

826 -  Zhuhai Livzon Diagnostics Inc. Diagnostic Kit for IgM Antibody to Corona Virus (nCoV-2019) (Colloidal Gold) (China NMPA EUA - Australia TGA - CE-IVD)

827 -  Zugotech Labs Ltd Zugotech COVID-19 IgM/IgG Rapid Test (In development)

828 -  Zybio Inc. SARS-CoV-2 IgM and IgG Antibody Assay Kit (CE-IVD)

829 -  Zybio, Inc. SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (Philippines FDA - CE-IVD)