CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Cell ID Pte Ltd. | Commercial: Smart COVID-19 IgM/IgG RDT | Device ID: 838 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Cellex Inc. | Commercial: Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test | Device ID: 116 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: CellSafe | Commercial: FastRT-qPCR COVID19 detection kit | Device ID: 119 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: CellSafe | Commercial: Qplex COVID-19 RT-qLAMP Assay | Device ID: 118 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: CellSafe | Commercial: UltrFast RT-qLAMP COVID19 Detection kit | Device ID: 117 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Centers for Disease Control and Prevention | Commercial: 2019 nCoV Real-Time RT-PCR Diagnostic Panel | Device ID: 417 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Centers for Disease Control and Prevention | Commercial: CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) | Device ID: 120 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Centrum Badań DNA ul. Ściegiennego 20 60-128 Poznań | Commercial: CBDNA RT-LAMP RAPID TEST | Device ID: 2567 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Cepheid | Commercial: Xpert SARS-CoV-2 Plus | Device ID: 5805 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Cepheid | Commercial: Xpert Xpress CoV-2/Flu/RSV plus | Device ID: 5806 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Cepheid | Commercial: Xpert Xpress SARS-CoV-2 | Device ID: 922 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: CerTest SARS-CoV-2 | Device ID: 1173 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit | Device ID: 1642 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX System | Device ID: 1643 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: VIASURE SARS-CoV-2 Real Time PCR Detection Kit | Device ID: 122 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit for BD MAX System | Device ID: 123 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec S.L | Commercial: VIASURE SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real Time PCR Detection Kit | Device ID: 2369 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec S.L | Commercial: VIASURE SARS-CoV-2 Variant I Real Time PCR Detection Kit | Device ID: 2370 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CerTest Biotec S.L | Commercial: VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit | Device ID: 2371 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP COVID19-INF A/B-RSV MULTI RAPID TEST KIT | Device ID: 5817 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST | Device ID: 2696 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASOPHARYNGEAL ANTIGEN TEST | Device ID: 2746 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CheckUp COVID-INF A/B-RSV COMBO RAPID NASAL TEST KIT | Device ID: 5820 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECKUP COVID-INF A/B-RSV-ADENO RAPID TEST KIT | Device ID: 5832 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changchun WanCheng Bio Electron Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2934 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changsha Sanji Bio-technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Method) | Device ID: 2990 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changsha Sinocare Inc. | Commercial: SARS-CoV-2 Antibody Test Strip | Device ID: 460 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changsha Sinocare Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2365 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Biowin COVID-19 Antigen Nasal Test (Self-test) | Device ID: 3148 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal) | Device ID: 2766 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)(For Nasal) | Device ID: 2641 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)(For Saliva)) | Device ID: 2749 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Device ID: 2588 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 2871 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Chastru Biotech Limited | Commercial: COVID-19 Antigen Test Cassette | Device ID: 3966 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Chembio Diagnostic Systems | Commercial: DPP COVID-19 IgM/IgG System | Device ID: 669 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: ChemGenes Corp. | Commercial: SARS-CoV-2 VoCs RT-qPCR Multiplex Kit | Device ID: 2849 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: CHIL Medical Supplies Ltd. | Commercial: CHiL COVID-19 IgG/IgM Rapid Test cassette | Device ID: 1098 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test | Device ID: 3864 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test (Nasal / Nasopharyngeal / Oropharyngeal Swab-Casette) | Device ID: 1691 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory | Commercial: SARS-CoV-2 RT-PCR test | Device ID: 713 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Chinese National Institute for Viral Disease Control and Prevention | Commercial: New coronavirus nucleic acid assay | Device ID: 127 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 2031 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit | Device ID: 1939 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (IgG) | Device ID: 1944 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (IgM) | Device ID: 1941 | Method: Immunochromatography | Target: IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (QDs) | Device ID: 1940 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Swab) | Device ID: 1938 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit(Swab) | Device ID: 1937 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: iSIA | Device ID: 2056 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements