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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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606 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: No Manufacturer: BioFire Diagnostics Commercial: BioFire COVID-19 test Device ID: 710 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioGX Commercial: SARS-CoV-2 in the Open System Reagents for BD MAX Device ID: 459 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BIOMAXIMA S.A. Commercial: SARS-CoV-2 Real Time PCR LAB-KIT Device ID: 89 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Biomeme Commercial: COVID-19 Go Strips Device ID: 91 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: bioMerieux Commercial: BioFire® Respiratory 2.1plus Panel Device ID: 1804 Method: RT-PCR Target: Nucleic acid Format: Automated Go to details
CE Marking: No Manufacturer: bioMérieux SA Commercial: BIOFIRE Respiratory Panel 2.1 (RP2.1) Device ID: 94 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: bioMérieux SA Commercial: SARS-COV-2 R-GENE (ref 432720) Device ID: 526 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: bioMérieux SA Commercial: SARS-COV-2 RESPI R-GENE Device ID: 2004 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: BIONEER Corporation Commercial: AccuPower COVID-19 Real-Time RT-PCR kit (lab-based automated kit: NCV-1111) Device ID: 527 Method: RT-PCR Target: Nucleic acid Format: Automated, Lab-based Go to details
CE Marking: Yes Manufacturer: BIONEER Corporation Commercial: AccuPower SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122) Device ID: 528 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: BIONEER Corporation Commercial: SCVR-2122 AccuPower SARS-CoV-2 Real-Time RT-PCR Kit (50 tests) Device ID: 529 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Bioperfectus Technologies Co. Ltd (Jiangsu) Commercial: COVID-19 Coronavirus Real Time PCR Kit Device ID: 962 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: BioRad Commercial: COVID-19 Droplet Digital PCR (ddPCR) Assay Device ID: 755 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioRad Commercial: Reliance One-Step RT-qPCR Supermix Device ID: 757 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioRad Commercial: SARS-CoV-2 / COVID-19 Assa Device ID: 99 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioRad Commercial: SARS-CoV-2 Negative Device ID: 98 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioRad Commercial: standard for SARS-CoV-2 Device ID: 97 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioReference Laboratories Commercial: Novel Coronavirus COVID-19 Device ID: 100 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BIORON Diagnostics GmbH Commercial: RealLine SARS CoV-2 Device ID: 1460 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: BIORON Diagnostics GmbH Commercial: RealLine SARS-CoV-2 lyo REF VBD5580 Device ID: 1459 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Biosearch Technologies Commercial: 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 Device ID: 733 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BIOSYNEX S.A. Commercial: BIOSYNEX AMPLIQUICK Respiratory Triplex Device ID: 1352 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: BIOSYNEX S.A. Commercial: BIOSYNEX AMPLIQUICK SARS-CoV-2 Device ID: 1351 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Biotech & Biomedicine (Shenyang) Group Ltd Commercial: Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus Device ID: 102 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
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: No Manufacturer: BIOTECON Diagnostics GmbH Commercial: Acu-Corona 2.0/3.0 SARS-CoV-2 Real-time PCR Kits Device ID: 530 Method: RT-PCR Target: Nucleic acid Format: Lab-based 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: No Manufacturer: BIOTECON Diagnostics GmbH Commercial: virusproof SL SARS-CoV-2 Real-time PCR Kit Device ID: 532 Method: RT-PCR Target: Nucleic acid Format: Lab-based 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: 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: Broad Institute Commercial: STOPCovid kit Device ID: 759 Method: Other 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: Yes Manufacturer: CapitalBio Technology Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip Method) Device ID: 2619 Method: LAMP Target: Nucleic acid Format: Automated, Lab-based, Near POC / POC 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: Caspr Biotech Commercial: Ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection Device ID: 647 Method: Other Target: Nucleic acid Format: Manual 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 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

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