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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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633 records found
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