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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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2163 records found
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