| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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 | 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 | 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 (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 (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 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: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: Verino Pro SARS CoV 2 Ag Rapid Test | Device ID: 2100 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Veredus Laboratories Pte Ltd | Commercial: VereCoV OneMix Detection Kit for VerePLEX Biosystem | Device ID: 419 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Eset Ltd | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 956 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 1077 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography) | Device ID: 1324 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay) | Device ID: 1326 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography) | Device ID: 1883 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag & FLU A/B Combo Rapid | Device ID: 1325 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (IFA) | Device ID: 1317 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) | Device ID: 1357 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) | Device ID: 1319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK SARS-CoV-2 Ag Rapid Test Kit | Device ID: 1314 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-Chek 2019-nCoV Ag Speichel Schnelltestkarte HGH | Device ID: 2244 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK 2019-nCoV Ag Rapid Test Kit | Device ID: 1316 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK 2019-nCoV Ag & FLU A/B Combo Rapid Test | Device ID: 1318 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: UNICELL-2019-nCoV NAb | Device ID: 1478 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: UNICELL-2019-nCoV Ag | Device ID: 1170 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Advanced Biological Laboratories SA | Commercial: UltraGene Combo2Screen SARS-CoV-2 Assay | Device ID: 764 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: U-TOP COVID-19 Detection Kit | Device ID: 347 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TP Medicare GmbH | Commercial: Trueline COVID-19 Ag Rapid Test | Device ID: 1497 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BOME TRIVITRON | Commercial: TRIMARIS SARS-CoV-2 RT-qPCR Kit | Device ID: 2259 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: Toyo SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1723 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: TOYO Covid-19 Ag Test | Device ID: 1722 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Total RNA Purification Kit Dx (Dx17200) | Device ID: 939 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Total Nucleic Acid Preservation Tubes Dx (Cat#Dx69200) | Device ID: 1175 | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA CORONADIAG Ag | Device ID: 1466 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: Toda Coronadiag + | Device ID: 1959 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd | Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) | Device ID: 77 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd | Commercial: Tigsun COVID-19 Antigen Saliva Rapid Test | Device ID: 1290 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd | Commercial: Tigsun COVID-19 Antigen Rapid Test | Device ID: 1292 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Theragen Genome Care | Commercial: Theragen COVID-19 ASSAY | Device ID: 2165 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: The SARS-CoV-2 Antigen Assay Kit (Immunochromatography) | Device ID: 1773 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GeneFirst Ltd | Commercial: The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit | Device ID: 926 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics s.r.l. | Commercial: TGS Velox Ag COVID-19 POCT SALIVA (25 test) | Device ID: 2274 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix, Inc. | Commercial: TestNOW® - COVID-19 NAb Quantitative Test | Device ID: 2134 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix, Inc. | Commercial: TestNOW® - COVID-19 IgG/IgM Test | Device ID: 2132 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix, Inc. | Commercial: TestNOW® - COVID-19 Antigen Test | Device ID: 2130 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid IgG/IgM 2019-nCoV | Device ID: 1073 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid Covid-19 Antigen (tampon nazofaringian) | Device ID: 1225 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian)) | Device ID: 1226 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen | Device ID: 1305 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc | Commercial: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test | Device ID: 524 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: TBG SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 1336 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath COVID-19 CE-IVD RT-PCR Kit | Device ID: 875 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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