| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Biotech & Biomedicine (Shenyang) Group Ltd. | Commercial: Real Time PCR Detection Kit For COVID-19 Coronavirus | Device ID: 101 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOTECON Diagnostics GmbH | Commercial: microproof SARS-CoV-2 Screening/Identification Kits | Device ID: 531 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Freeze-dried Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit （Fluorescence PCR method） | Device ID: 2149 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co. Ltd. | Commercial: Freeze-dried Novel Coronavirus (COVID-19) nucleic acid detection kit （Fluorescence PCR method） | Device ID: 1856 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Fluorescence PCR method) | Device ID: 1486 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biotrack B.V. | Commercial: BTMED | Device ID: 1597 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: Bosch Healthcare Solutions | Commercial: Vivalytic SARS-CoV-2 Pooling | Device ID: 2976 | Method: RT-PCR | Target: | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bosch Healthcare Solutions GmbH | Commercial: Vivalytic SARS-CoV-2 | Device ID: 2977 | Method: RT-PCR | Target: | Format: Automated, Near POC / POC | 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: 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: 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: Chronomics Limited | Commercial: SaliVIR COVID 19 Rapid Multiplex qRT-PCR Kit | Device ID: 1181 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Chronomics Limited | Commercial: SaliVIR Rapid Multiplex COVID19 vRNA Test | Device ID: 1110 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-COV-2 RT-qPCR Assay | Device ID: 1388 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Clonit | Commercial: quanty-CONV-19 | Device ID: 129 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Co-diagnostics | Commercial: Logix Smart Coronavirus disease 2019 (COVID-19) | Device ID: 130 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Convergent Technologies | Commercial: Convergys POC RT-PCR COVID-19 Detectin Kit | Device ID: 1734 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Coyote Bioscience Co. Ltd. | Commercial: 2019-nCoV Prep Free QPCR Assay | Device ID: 134 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Coyote Bioscience Co. Ltd. | Commercial: DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) | Device ID: 1866 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Credo Diagnostics Biomedical | Commercial: VitaPCR COVID-19 assay | Device ID: 141 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: Aridia COVID-19 Real Time PCR Test | Device ID: 143 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DAAN Gene Co. Ltd. of Sun Yat-sen University | Commercial: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit | Device ID: 144 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Kit Multiplex (q)RT-PCR(X) for detection of SARS-CoV-2 | Device ID: 2657 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 RNA Vs 2 | Device ID: 2460 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: VZV DNA QUANTITATION (QT) | Device ID: 2466 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Diacarta Inc. | Commercial: QuantiVirus SARS-CoV-2 Multiplex Test Kit | Device ID: 1404 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Diacarta Inc. | Commercial: QuantiVirus SARS-CoV-2 test kit | Device ID: 716 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diacarta Inc. | Commercial: Quantivirus SARS-CoV-2 Variants Detection Kit | Device ID: 3034 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Other | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-1 SARS-CoV-2 OneStep RT-PCR Kit (S-Gene) | Device ID: 1121 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-2 SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Device ID: 540 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-3 SARS-CoV-2 Direct OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Device ID: 1122 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: Diagnostic Automation, Inc. SARS-CoV-2 RT-PCR Kit | Device ID: 1194 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostics for the Real World Ltd. | Commercial: SAMBA II COVID-19 Test (near-POC NAT) | Device ID: 147 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: Simplexa COVID-19 Direct RT-PCR Kit | Device ID: 471 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Diatech Pharmacogenetics | Commercial: Easy SARS-CoV-2 | Device ID: 843 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diatheva SRL | Commercial: COVID-19 PCR DIATHEVA Detection kit | Device ID: 148 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DNA-Technology R&D LLC | Commercial: SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit | Device ID: 1109 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: Novel Coronavirus(2019-nCov)RT-PCR Kit | Device ID: 151 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: COVID-19 Real-time PCR Testing Kit | Device ID: 155 | 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