CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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: No | Manufacturer: Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) | Commercial: Childrens-Altona-SARS-CoV-2 assay | Device ID: 712 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Canvax Biotech | Commercial: qMAXSen Coronavirus (SARS-CoV-2) RT-qPCR Detection Kit | Device ID: 470 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: CapitalBio Technology | Commercial: Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) | Device ID: 114 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Caspr Biotech | Commercial: Phantom 1.0 Dx (near POC) | Device ID: 115 | Method: CRISPR | Target: Nucleic acid | 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: 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: 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: 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: No | Manufacturer: ChromaCode | Commercial: ChromaCode COVID-19 Six Target Single Well Assay | Device ID: 128 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: ChromaCode | Commercial: HDPCR SARS-CoV-2 real-time PCR assay | Device ID: 714 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: CirrusDx Laboratories | Commercial: CirrusDx SARS-CoV-2 Assay | Device ID: 715 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: Curative Inc. (in conjunction with KorvaLabs Inc) | Commercial: Curative-Korva SARS-Cov-2 Assay | Device ID: 536 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: No | Manufacturer: Diagnostic Solutions Laboratory | Commercial: COVID-19 Assay | Device ID: 146 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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 |
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