| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 SNPs | Device ID: 2275 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: EURORealTime SARS-CoV-2 | Device ID: 159 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: ExAmplar COVID-19 real-time PCR kit (L) | Device ID: 104 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: ExAmplex Influenza A/B SARS-CoV-2 PCR kit | Device ID: 1450 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biosensor, Inc | Commercial: Exdia COVID-19 Ag | Device ID: 1271 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EXON BIYOMEDIKAL | Commercial: EXON SARS-CoV-2 Real Time PCR Tanı Kiti | Device ID: 1738 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 KIT 1-RQ | Device ID: 2064 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 VRT KIT 2-RQ | Device ID: 2065 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: ExProbe SARS-CoV-2 Testing Kit | Device ID: 1335 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Randox Laboratories Ltd | Commercial: Extended Coronavirus Array | Device ID: 334 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Prantae Solutions Pte Ltd | Commercial: EyeRa-Covid | Device ID: 314 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. ltd. şti. | Commercial: FAMEX Coronavirus (2019-nCoV) Antigentest | Device ID: 2172 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: FAGO MEDİKAL SANAYİ TİCARET LTD. ŞTİ. | Commercial: FAMEX Coronavirus (2019-nCoV) Antigentest | Device ID: 2053 | Method: Immunochromatography | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. ltd. şti. | Commercial: FAMEX SARS-CoV-2 AG RAPID NASOPHARTNGEAL TEST KIT | Device ID: 2173 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. ltd. şti. | Commercial: FAMEX SARS-CoV-2 RAPID ANTIBODY TEST | Device ID: 2175 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. ltd. şti. | Commercial: FAMEX SARS-CoV-2 SALIVA ANTIGEN TEST KIT | Device ID: 2174 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: DNA Xperts Pvt Ltd | Commercial: FAST RT-PCR KIT, Real time PCR kit for COVID19 detection | Device ID: 542 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Superbio Biomedical Technology (Nanjing) Co., Ltd | Commercial: Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold) | Device ID: 240 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: MGI Tech Co., Ltd | Commercial: Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation | Device ID: 483 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Fast Track Diagnostics (FTD) SARS-CoV-2 Assay | Device ID: 747 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: FaStep COVID-19 Antigen Nasal Test Kit | Device ID: 2469 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: Fastep COVID-19 Antigen Rapid Test Device | Device ID: 2364 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1669 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 Antibody Test | Device ID: 206 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 IgG Test | Device ID: 1191 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 IgM/IgG Test | Device ID: 1211 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WHPM | Commercial: First Sign SARS-CoV-2-Antigen-Test | Device ID: 1724 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GVS S.p.A. | Commercial: Flame CoViD -19 VARIANTS qPCR Master Kit – CE-IVD | Device ID: 2445 | Method: RT-PCR | Target: | Format: Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Flowflex SARS-CoV-2 Antigen rapid test | Device ID: 1468 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: Flu A/B + COVID-19 Antigen Combo Test Cassette Kit | Device ID: 2340 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: Flu A/Flu B/SARS-CoV-2 Antigen (GICA) | Device ID: 1713 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: Flu+COVID-19 Ag Test Kit | Device ID: 1470 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device | Device ID: 1370 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: FluCov2 | Device ID: 1664 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd. | Commercial: fluorecare SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2181 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd. | Commercial: fluorecare SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay) | Device ID: 2182 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd. | Commercial: fluorecare SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay) | Device ID: 2168 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Qitian Gene Biotechnology Co., Ltd | Commercial: Fluorescent RAA Detection for 2019-nCoV | Device ID: 239 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Iontek | Commercial: Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit | Device ID: 1721 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Other, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Medical & Biological Laboratories Co., Ltd | Commercial: FLUOROSEARCH Novel Coronavirus (SARS-CoV-2) Detection Kit | Device ID: 274 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Fluxergy LLC | Commercial: Fluxergy Sample-to-Answer SARS-CoV-2 RT-PCR | Device ID: 167 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PharmaNona | Commercial: FOAMING TEST | Device ID: 1447 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: FORA COVID-19 Antigen Rapid Test | Device ID: 1192 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Foresight SARS-CoV-2 IgG | Device ID: 1424 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgG EIA Test Kit | Device ID: 1671 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Foresight SARS-CoV-2 IgM | Device ID: 1425 | Method: Immunoassay | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgM EIA Test Kit | Device ID: 1672 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Formosa Biomedical Technology Corp. | Commercial: Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit | Device ID: 1208 | 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