ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Coronavirus

EMDN code W01050411

81 manufacturers, 400 models including 356 on the market, 19 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 81

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Wuhan Easydiagnosis Biomedicine EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + throat swab)98/79 76 others COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit （Nasal swab）98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short version)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short versionNasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit ( Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit(Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit(Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit(Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-B0198/79 COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C0198/79 COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-B0198/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab + throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit (Positive control)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit(Positive and negative controls)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab (short version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Positive control)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit(Nasal swab + anterior nasal swab (short version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-5, 5Tests/kit (Nasal swab + throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C10,98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C2098/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o	Czechia	CLIA COVID-19 NP IgA98/79 CLIA COVID-19 NP IgG98/79 CLIA COVID-19 NP IgM98/79 CLIA COVID-19 RBD IgA98/79 CLIA COVID-19 RBD IgG98/79 16 others CLIA COVID-19 RBD IgM98/79 EIA COVID-19 NP IgA98/79 EIA COVID-19 NP IgG98/79 EIA COVID-19 NP IgM98/79 EIA COVID-19 RBD IgA98/79 EIA COVID-19 RBD IgG98/79 EIA COVID-19 RBD IgM98/79 Microblot-Array COVID-19 IgA98/79 Microblot-Array COVID-19 IgG98/79 Microblot-Array COVID-19 IgM98/79 SmartEIA COVID-19 NP IgA98/79 SmartEIA COVID-19 NP IgG98/79 SmartEIA COVID-19 NP IgM98/79 SmartEIA COVID-19 RBD IgA98/79 SmartEIA COVID-19 RBD IgG98/79 SmartEIA COVID-19 RBD IgM98/79	– 98/79	Website info@testlinecd.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	2019-CoV IgG/IgM Rapid Test Cassette2 refs98/79 COVID-19 Antigen Rapid Test3 refs98/79 COVID-19 Antigen Rapid Test (Corona Lollipop Rapid Test)98/79 COVID-19 Antigen Test Cassette2 refs98/79 COVID-19 Antigen Test Cassette(Swab)2 refs98/79 15 others COVID-19 IgG Rapid Test3 refs98/79 COVID-19 IgG/IgM Rapid Test2 refs98/79 COVID-19 IgG/IgM Rapid Test Dipstick2 refs98/79 COVID-19 IgG/IgM Test Cassette98/79 COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test98/79 COVID-19 S-RBD IgG Antibody Test Cassette98/79 COVID-19 S-RBD IgG Quantitative Test Cassette98/79 One Step SARS-CoV-2 (COVID-19) Antigen Rapid Test98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test2 refs98/79 SARS-CoV-2 and Variant Delta Virus RT-qPCR Kit98/79 SARS-CoV-2 Antigen Rapid Test2 refs98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-COV-2 RT-qPCR Assay98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79 SARS-CoV-2 Variant Omicron Virus RT-qPCR Kit98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	2019-nCoV Antigen Rapid Test Cassette28 refs98/79 2019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab98/79 2019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab98/79 2019-nCoV Antigen Rapid Test Cassette Saliva98/79 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method)7 refs98/79 13 others 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method)116 refs98/79 ARMS-PCR Detection Kit for 2019-nCoV HV69-70del and N501Y mutation98/79 ARMS-PCR Detection Kit for SARS-CoV-2 L452R and E484Q Mutation98/79 ARMS-PCR Diagnostic Detection Kit for 2019-nCoV HV69-70del and N501Y mutation98/79 Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N5 refs98/79 Duplex Real-Time PCR Kit for Rapid Detection of 2019-nCoV ORF1ab/N gene98/79 Multiple Real-Time PCR Kit for Detection of 2019-nCoV6 refs98/79 SARS-CoV-2 Antigen Rapid Test Cassette4 refs98/79 SARS-CoV-2 Antigen Rapid Test Cassette Anterior Nasal Swab98/79 SARS-CoV-2 Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab98/79 SARS-CoV-2 Antigen Rapid Test Cassette Saliva98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)98/79	– 98/79	EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	2019-nCoV IgG/IgM Rapid Test Cassette (Single use kit)98/79 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 refs98/79 COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)2 refs98/79 COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 Antigen Rapid Test Strip (Nasopharyngeal Swab)98/79 11 others COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)98/79 COVID-19 Antigen Test Cassette (Oral Fluid)98/79 COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)2 refs98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 IgG/IgM Rapid Test Dipstick (Whole Blood/Serum/Plasma)2 refs98/79 COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)98/79 COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test(Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD IgG Quantitative Test Cassette (Whole Blood /Serum /Plasma)98/79 SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 SARS-COV-2 RT-qPCR Assay98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain)	China	1 T/kit98/79 1 Test/Kit2 refs98/79 10 T/kit98/79 10 test /kit98/79 10 Tests/Kit98/79 10 others 100 test /kit98/79 100 Tests/Kit98/79 100T/kit98/79 20 test /kit98/79 20 Tests/Kit98/79 20T/kit98/79 25 test/kit98/79 40 T/kit98/79 40 test /kit98/79 40 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Monobind FDA EU representative : AR Experts B.V. (Netherlands)	United States	Anti-SARS-CoV-2 IgA AccuBind ELISA Kit - 192 wells 11825-300B98/79 Anti-SARS-CoV-2 IgA AccuBind ELISA Kit - 96 wells 11825-300A98/79 Anti-SARS-CoV-2 IgA AccuLite CLIA Kit - 192 wells 11875-300B98/79 Anti-SARS-CoV-2 IgA AccuLite CLIA Kit - 96 wells 11875-300A98/79 Anti-SARS-CoV-2 IgG AccuBind ELISA Kit - 192 wells 11925-300B98/79 9 others Anti-SARS-CoV-2 IgG AccuBind ELISA Kit - 96 wells 11925-300A98/79 Anti-SARS-CoV-2 IgG AccuLite CLIA Kit - 192 wells 11975-300B98/79 Anti-SARS-CoV-2 IgG AccuLite CLIA Kit - 96 wells 11975-300A98/79 Anti-SARS-CoV-2 IgM AccuBind ELISA Kit - 192 wells 11725-300B98/79 Anti-SARS-CoV-2 IgM AccuBind ELISA Kit - 96 wells 11725-300A98/79 Anti-SARS-CoV-2 IgM AccuLite CLIA Kit - 192 wells 11775-300B98/79 Anti-SARS-CoV-2 IgM AccuLite CLIA Kit - 96 wells 11775-300A98/79 Anti-SARS-CoV-2 S1-RBD IgG (COVID-19 S1-RBD IgG) AccuBind® ELISA Test System 12525-300B98/79 Anti-SARS-CoV-2 S1-RBD IgG AccuBind ELISA Kit - 96 wells 12525-300A98/79	– 98/79	Website info@monobind.com EUDAMED record Report an error
Immundiagnostik FDA	Germany	IDK® anti-SARS-CoV-2 IgG ELISA2 refs98/79 IDK® anti-SARS-CoV-2 IgG ELISA DBS98/79 IDK® anti-SARS-CoV-2 IgM ELISA98/79 MutaPLEX® Coronavirus98/79 MutaPlex® Coronavirus 4G, PCR3 refs98/79 6 others MutaPlex® Coronavirus, PCR2 refs98/79 MutaPlex® CoV-2 MUT 2, PCR98/79 MutaPlex® CoV-2 MUT 3, PCR2 refs98/79 MutaPlex® CoV-2 MUT, PCR98/79 MutaPlex® SC2 multi gene, PCR3 refs98/79 PreventID® SARS-CoV-2 Antigen98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	Ireland, United States	Alinity 06S612098/79 ALINITY M SARS-COV-22 refs Alinity SARS-CoV-2 IgG98/79 Alinity SARS-CoV-2 IgG II Quant3 refs Alinity SARS-CoV-2 IgM98/79 4 others ARCHITECT 06S602098/79 ARCHITECT SARS-CoV-2 IgG98/79 ARCHITECT SARS-CoV-2 IgG II Quant3 refs ARCHITECT SARS-CoV-2 IgM98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	Truemix COVID-19 70143000898/79 Truemix COVID-19 70143002498/79 Truemix COVID-19 70143004898/79 Truemix COVID-19 70143009698/79 Truenat COVID-19 60143000598/79 3 others Truenat COVID-19 60143002098/79 Truenat COVID-19 60143002598/79 Truenat COVID-19 60143005098/79	– 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Ablsa	Luxembourg	UltraGene Assay SARS-CoV-298/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (1000 tests, liquid)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (50 tests, liquid)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (96 tests, lyophilized)98/79 UltraGene Assay SARS-CoV-2 VOC Screening & Determination V1.X98/79 2 others UltraGene Assay SARS-CoV-2 Universalis V2.X (1000 tests)98/79 UltraGene Assay SARS-CoV-2 Universalis V2.X (50 tests)98/79	– 98/79	Website contact@ablsa.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) ACAB0298/79 SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) ACOV0198/79 SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) ACOV0298/79 SARS-CoV-2 Detection Kit (Fluorescence RT-PCR) ACOV0398/79 SARS-CoV-2 K417N/E484K Mutations Detection Kit (Fluorescence PCR) ACOV0598/79 2 others SARS-CoV-2 N501Y/HV69-70del Mutations Detection Kit (Fluorescence PCR) ACOV0498/79 Vaginal pH Rapid Test Cassette (Swab) VPH-502a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-MERS-CoV ELISA (IgG) EI 2604 G98/79 Anti-SARS-CoV-2 ELISA (IgA) EI 2606 A98/79 Anti-SARS-CoV-2 ELISA (IgG) EI 2606 G98/79 Anti-SARS-CoV-2 NCP ELISA (IgG) EI 2606-2 G98/79 Anti-SARS-CoV-2 QuantiVac ELISA (IgG) EI 2606-10 G98/79 1 other Anti-SARS-CoV-2 RBD ChLIA (IgG) LI 2606-1 G98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	GSD NovaLisa SARS-CoV-2 (COVID-19) quantitative IgG98/79 GSD NovaPrime® TSP SARS-CoV-22 refs98/79 NovaLisa® SARS-CoV-2 (COVID-19) IgA98/79 NovaLisa® SARS-CoV-2 (COVID-19) IgG98/79 SARS-CoV-2 (COVID-19) IgA98/79 1 other SARS-CoV-2 (COVID-19) IgG98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Singclean EU representative : SUNGO Europe B.V. (Netherlands)	China	FASUAL COVID-19 Test kit (Colloidal Gold Method)98/79 Singclean® COVID-19 Antigen Test kit (Colloidal Gold Method)4 refs98/79 Singclean® COVID-19 IgG Test kit (Colloidal Gold Method)2 refs98/79 Singclean® COVID-19 IgM Test kit (Colloidal Gold Method)4 refs98/79 Singclean® COVID-19 Neutralizing Antibody Test Kit(Colloidal Gold)4 refs98/79 1 other Singclean® COVID-19 Test kit (Colloidal Gold Method)6 refs98/79	– 98/79	Website EUDAMED record Report an error
Vircell	Spain	COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST VCM10098/79 COVID-19 VIRCLIA® IgG MONOTEST VCM09798/79 COVID-19 VIRCLIA® IgM+IgA MONOTEST VCM09898/79 DIRECT SARS-COV-2 REALTIME PCR KIT RTPCR0023 refs98/79 SARS-COV-2 OMICRON REALTIME PCR KIT RTPCR01298/79 1 other SARS-COV-2 PLUS UK REALTIME PCR KIT RTPCR0092 refs98/79	– 98/79	EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : SUNGO Europe B.V. (Netherlands)	China	SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) 48 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) 96 tests/kit98/79 SARS-CoV-2 Nucleic Acid Dual-Detection Kit (Real-Time PCR Method) 25 tests/kit98/79 SARS-CoV-2 Nucleic Acid Dual-Detection Kit (Real-Time PCR Method) 50 tests/kit98/79 SARS-CoV-2 S-RBD IgG Antibody Assay Kit (ELISA) 48 tests/kit98/79 1 other SARS-CoV-2 S-RBD IgG Antibody Assay Kit (ELISA) 96 tests/kit98/79	– 98/79	EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit98/79 Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit (Fluorescence)98/79 SARS-CoV-2 Nucleic Acid Detection Kit2 refs98/79 SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence Screening)98/79 SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	EUDAMED record Report an error
Mikrogen	Germany	recomLine SARS-CoV-2 IgG [Avidität]98/79 recomWell SARS-CoV-2 IgA98/79 recomWell SARS-CoV-2 IgG98/79 T-Track® SARS-CoV-2 Quant PCR98/79 T-Track® SARS-CoV-2 Stimulation98/79	– 98/79	EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) 20 Tests/kit98/79 Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) 50 Tests/kit98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/ kit98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 96 tests/ kit98/79 Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 Tests/Kit;2 refs98/79	– 98/79	EUDAMED record Report an error
altona Diagnostics FDA	Germany	AltoStar® MERS-CoV RT-PCR Kit 1.598/79 AltoStar® SARS-CoV-2 RT-PCR Kit 1.598/79 RealStar® MERS-CoV RT-PCR Kit 1.098/79 RealStar® SARS-CoV-2 RT-PCR Kit 1.098/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany)	China	2019-nCoV Antigen Rapid Test Kit 25 tests/box 2019-nCoV IgG Antibody Determination Kit 25 tests/box 2019-nCoV IgG/gM Antibody Rapid Test Kit 25 tests/box 2019-nCoV IgM Antibody Determination Kit 25 tests/box	B IVDR	Website info@diagreat.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit2 refs98/79 RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)3 refs98/79 RevoDx SARS-CoV-2 qPCR Kit v2.22 refs98/79 RevoDx SARS-CoV-2 qPCR Kit v2.32 refs98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)11 refs98/79 2019-Novel Coronavirus, Influenza A and B Virus Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)2 refs98/79 2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)98/79 SARS-CoV-2 Realtime PCR Test Kit (Lyophilized)4 refs98/79	– 98/79	EUDAMED record Report an error
Thermofisher FDA EU representative : Life Technologies Europe B.V. (Netherlands)	United States	TaqPath™ 1-Step Multiplex Master Mix (No ROX)2 refs98/79 TaqPath™ COVID-19 Control2 refs98/79 TaqPath™ COVID-19 Control Dilution Buffer98/79 TaqPath™ COVID-19 RT-PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	COVID-19 EASY PREP PCR TANI KİTİ COVID-19 EASY-PREP PCR DIAGNOSTIC KIT COVID-19 MULTIPREP FAST SARS-COV-2 MUTATION DETECTION KİT VISION COVID-19 EASYPREP-FAST PCR DIAGNOSTIC KIT	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	SARS-CoV-2 Detection and Monitoring Kit (24)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (48)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (96)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS COVID-19 Ag98/79 EZ POC COVID-19 Ag98/79 ichroma™ COVID-19 Ag98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Capitalbiotech EU representative : SUNGO Europe B.V. (Netherlands)	China	12 tests/kit98/79 32 tests/kit98/79 96 tests/kit98/79	– 98/79	EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	Italy, United States	LIAISON® SARS-CoV-2 Ag LIAISON® SARS-CoV-2 TrimericS IgG98/79 Simplexa™ COVID-19 Direct98/79	B IVDR, 98/79	Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Latex Chromatography)98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RNA Amplification Lateral Flow)98/79	– 98/79	EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.098/79 PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2 Real-time PCR Kit98/79	– 98/79	Website info@kogene.co.kr EUDAMED record Report an error
Microbiologics FDA EU representative : MediMark Europe Sarl. (France)	United States	ABT-001 HE0065N HE0066NS	B IVDR	Website info@microbiologics.com EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit3 refs Poly Diagnostics Coronaviruses 229E/HKU1, OC43, NL63, RNase P Real-Time PCR kit3 refs Poly Diagnostics SARS-CoV-2, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	100 Tests/Kit2 refs98/79 200 Tests/Kit2 refs98/79 50 Tests/Kit4 refs98/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ 2019-nCoV Assay2 refs98/79 Allplex™ SARS-CoV-2 Assay2 refs98/79 Allplex™ SARS-CoV-2 fast PCR Assay2 refs98/79	– 98/79	Website info@seegene.com EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR HCoV98/79 Vitassay qPCR SARS-CoV-298/79 Vitassay qPCR SARS-CoV-2 (ORF1ab, E & N)98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	100 Tests/kit3 refs98/79 50 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
AD Nucleis	France	AD Nucléis direct SARS-CoV-2_1-step RTCPR 48R98/79 AD Nucléis direct SARS-CoV-2_1-step RTCPR 96R98/79	– 98/79	Website EUDAMED record Report an error
Arcdia	Finland	mariPOC® Human coronavirus OC43 test reagent98/79 mariPOC® SARS-CoV-2 test reagent98/79	– 98/79	Website office@arcdia.com EUDAMED record Report an error
Bio-Novum	Poland	BN SARS CoV 2 Ag Rapid Test98/79 BN SARS CoV 2 IgG/IgM Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® SARS-CoV-2 N RT-qPCR Kit2 refs98/79 Bio-Speedy® SARS-CoV-2 Triple Gene RT-qPCR Kit4 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit BSJ18S198/79 SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit BSJ18S1S98/79	– 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden)	United States	Xpert® Xpress CoV-2 plus98/79 Xpert® Xpress SARS-CoV-298/79	– 98/79	Website EUDAMED record Report an error
Certest	Spain	VIASURE Coronavirus 229E, NL63, OC43 & HKU1 Real Time PCR Detection Kit3 refs VIASURE SARS-CoV-2 Real Time PCR Detection Kit3 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR SARS-CoV-2 Assay98/79 VitaPCR SARS-CoV-2 Gen 2 Assay98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	20 tests/kit98/79 25 tests/kit3 refs98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
Geneproof	Czechia	GeneProof SARS-CoV-2 Advanced PCR Kit2 refs98/79 GeneProof SARS-CoV-2 Screening MC PCR Kit2 refs98/79	– 98/79	Website support@geneproof.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	Lyra Direct SARS-CoV-298/79 Lyra SARS-CoV-2 Assay98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany)	South Korea	Exdia COVID-19 Ag98/79 PBCheck COVID-19 Ag98/79	– 98/79	Website info@precision-bio.com EUDAMED record Report an error
Progenie molecular S.L.U	Spain	RealCycler CORO-ABI32 v.6.298/79 RealCycler CORO-UX v.6.298/79	– 98/79	EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®GENE SARS-CoV-298/79 RIDA®UNITY SARS-CoV-2 DT	B IVDR, 98/79	Website EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain)	China	10 tests/kit98/79 50 tests/kit98/79	– 98/79	sale@rocgene.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)98/79 Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	LightMix®KIT MERS-CoV upE N orf1a LightMix® Kit MERS-CoV upE N orf1a98/79 LightMix®KIT Sarbecovirus SARS-CoV-2 LightMix® Modular Sarbecovirus SARS-CoV-298/79	– 98/79	Website EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 1 other	China	2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit CD302-0298/79 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit CD312-0298/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	LyoSens SARS-CoV-2 qPCR Kit LYO106WS9698/79 LyoSens™ SARS-CoV-2 qPCR Kit2 refs	B IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit98/79 QINGLI Strip: 25Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	S3102E-242 refs Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) SARS Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)4 refs98/79 (no longer marketed)	B IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
1drop EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	1copy™ COVID-19 qPCR 4plex Kit M2498/79	– 98/79	Website sales@1drop.co.kr EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	30014298/79	– 98/79	Website EUDAMED record Report an error
Anchor Diagnostics	Germany	Anchor SARS-CoV-2 PCR Kit v2.098/79	– 98/79	info@anchor-diagnostics.com EUDAMED record Report an error
Appolon Bioteck	France	SARS-CoV-2 RT-qPCR DETECTION KIT98/79	– 98/79	Website contact@appolonbioteck.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	BD Respiratory Viral Panel-SCV2 for BD MAX™ System	B IVDR	Website EUDAMED record Report an error
Beijing Microfuture Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction98/79	– 98/79	EUDAMED record Report an error
bioMérieux FDA	France	COVID-19 R-GENE®	B IVDR	EUDAMED record Report an error
Biosynex	France	BIOSYNEX AMPLIQUICK SARS-CoV-23 refs98/79	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Dianabiotech	Czechia	DBdirect™ COVID-19 Multiplex RT-PCR Kit2 refs98/79	– 98/79	Website info@dianabiotech.com EUDAMED record Report an error
FRIZ Biochem	Germany	COVID-19 direct RT-PCR	B IVDR	Website info@frizbiochem.de EUDAMED record Report an error
gerbion	Germany	virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.098/79	– 98/79	info@gerbion.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay)7 refs98/79	– 98/79	EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima SARS-CoV-2 Assay2 refs	B IVDR	EUDAMED record Report an error
Id Solutions	France	IDTM SARS-CoV-2/Influenza TriplexIDTM SARS-CoV-2/Influenza Triplex IDRESPI-P1-500 (FR) - Boîtes98/79	– 98/79	Website info@id-solutions.fr EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	12 reaction/kit98/79	– 98/79	support@igenesisbio.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 Antigen Rapid Test Kit (QDs Immunofluorescence Method) SARS-CoV-2-QD98/79	– 98/79	Website EUDAMED record Report an error
PathoFinder	Netherlands	RealAccurate® Quadruplex Corona PCR kit PF0971-R98/79	– 98/79	Website info@pathofinder.com EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	PaxView® SARS-CoV-2 real-time RT-PCR Kit R050298/79	– 98/79	Website EUDAMED record Report an error
Pluslife EU representative : Kingsmead Service B.V. (Netherlands)	China	Pluslife SARS-CoV-2 Card SARS-CoV-2 Nucleic Acid Testing Card98/79	– 98/79	Website ra@pluslife.com EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ M10 SARS-CoV-2 M-NCOV-0398/79	– 98/79	Website EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test COIF-52298/79	– 98/79	Website EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) No model still on the market	Japan	CL AIA-PACK SARS-CoV-2-Ag ADJUSTER SET98/79 (no longer marketed) CL AIA-PACK SARS-CoV-2-Ag CONTROL SET98/79 (no longer marketed) CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION98/79 (no longer marketed) CL AIA-PACK SARS-CoV-2-Ag TEST CUP98/79 (no longer marketed)	– 98/79	csc@tosoh.co.jp EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 42

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories	United States	VITROS	registered
Beckman Coulter, Inc. Present in Europe in other categories	United States	Access SARS-CoV-2 IgM QC Access SARS-CoV-2 IgG II Access SARS-CoV-2 IgG II Calibrator Access SARS-CoV-2 IgM Access SARS-CoV-2 IgG Access SARS-CoV-2 IgM Calibrator	registered
Life Technologies Corporation	United States	Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control	K233453 (2024)
Roche Molecular Systems, Inc.	United States	cobas® SARS-CoV-2 Qualitative 192T cobas® SARS-CoV-2 Qualitative Control Kit cobas® SARS-CoV-2 Qualitative 480T	K240867 (2025)
Biofire Defense, LLC	United States	BioFire® COVID-19 Test 2	K221460 (2022)
INBIOS INTERNATIONAL, INC Present in Europe in other categories	United States	SCoV-2 Detect™ IgM ELISA SCoV-2 Detect™ IgG ELISA	registered
Jiangsu Bioperfectus Technologies Co., Ltd. Present in Europe in other categories	–	COVID-19 Coronavirus Real Time PCR Kit	registered
NanoEnTek, Inc. Present in Europe in other categories	United States	FREND COVID-19 total Ab COVID-19 total Ab Control LQ	registered
Phadia AB Present in Europe in other categories	Sweden	EliA SARS-CoV-2-Sp1 IgG Well EliA CoV Positive Control C1 250	registered
ACON Laboratories, Inc.	United States	ACON SARS-CoV-2 IgG/IgM Rapid Test	registered
Agilent Technologies, Inc. Present in Europe in other categories	United States	SARS-CoV-2 IgG ELISA Kit	registered
Assure Tech. (Hangzhou) Co., Ltd.	China	Fastep COVID-19 IgG/IgM Rapid Test Device	registered
BTNX Inc	–	Rapid Response	registered
Bio-Rad Present in Europe in other categories	United States	Platelia	registered
Biohit Healthcare (Hefei) Co., Ltd. Present in Europe in other categories	China	Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit	registered
Hangzhou Laihe Biotech Co.,Ltd. Present in Europe in other categories	China	Lyher	registered
Immunodiagnostic Systems , Ltd. Present in Europe in other categories	United Kingdom	IDS SARS-COV-2 IgG	registered
LUMIQUICK DIAGNOSTICS, INC.	United States	QuickProfile™ 2019-nCoV IgG/IgM Antibody Test	registered
NANO-DITECH CORPORATION	United States	Nano-CheckTM COVID-19 IgG/IgM Antibody Test	registered
QUALIGEN INC. Present in Europe in other categories	United States	FastPack SARS-CoV-2 IgG	registered
823404997	United States	–	registered
Access Bio, Inc.	United States	–	registered
Advin Biotech Inc	United States	–	registered
Atlas Link Inc.	United States	–	registered
Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories	France	–	registered
Diagnostic Automation /Cortez Diagnostics Inc.	United States	–	registered
Diazyme Laboratories Present in Europe in other categories	United States	–	registered
Fujirebio Diagnostics,Inc. Present in Europe in other categories	United States	–	registered
Hangzhou Biotest Biotech Co.,Ltd. Present in Europe in other categories	China	–	registered
Hangzhou Rollmed Co.,Ltd.	China	–	registered
Innovita (Tangshan) Biological Technology Co., Ltd.	China	–	registered
PHAMATECH INC.	United States	–	registered
QuidelOrtho Corporation	United States	–	registered
Roche Diagnostics Operations Inc.	United States	–	registered
Salofa Oy Present in Europe in other categories	Finland	–	registered
Scantibodies Laboratory Inc.	United States	–	registered
Shenzhen Lifotronic Technology Co., Ltd. Present in Europe in other categories	China	–	registered
Shijiazhuang Hipro Biotechnology Co., Ltd. Present in Europe in other categories	China	–	registered
Watmind USA	United States	–	registered
Zeus Scientific, Inc. Present in Europe in other categories	United States	–	registered
Zhejiang GENE SCIENCE Co., Ltd	China	–	registered
Zhejiang Orient Gene Biotech Co., Ltd Present in Europe in other categories	China	–	registered

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