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)
