| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Beijing Shengkun Kangru Medical Equipment Co. Ltd. | Commercial: 2019-nCoV Detection kit (quantum dot immunofluorescence method) | Device ID: 78 | Method: Other | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: Wantai SARS-CoV-2 RT-PCR Kit | Device ID: 81 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [FluA/FluB/SARS-CoV-2] RT-PCR kit - 48 | Device ID: 5731 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [FluA/FluB/SARS-CoV-2] RT-PCR kit - for Chronos Dx | Device ID: 5730 | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [SARS-CoV-2] RT-PCR kit - 48 | Device ID: 5729 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [SARS-CoV-2] RT-PCR kit - for Chronos Dx | Device ID: 5728 | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BGI | Commercial: 2019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method | Device ID: 83 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BGI | Commercial: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 | Device ID: 920 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BillionToOne Inc. | Commercial: qSanger-COVID-19 Assay | Device ID: 1401 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Bio Basic Inc. | Commercial: SARS-CoV- RT-PCR Detection Kit | Device ID: 921 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Bio-Rad SARS CoV-2 ddPCR Assay | Device ID: 541 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019-nCoV) RT-qPCR Detection Kit | Device ID: 2900 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2 Test | Device ID: 2662 | Method: RT-PCR | Target: Nucleic acid | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Biocerna | Commercial: SARS-CoV-2 Test | Device ID: 708 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BioCore | Commercial: BioCore 2019-nCoV Real Time PCR Kit | Device ID: 1402 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test | Device ID: 758 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: SARS-CoV-2 Droplet Digital PCR (ddPCR) test | Device ID: 709 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Bioeksen R&D Technologies Ltd. | Commercial: Bio-Speedy Direct RT-qPCR SARS-CoV-2 | Device ID: 1060 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioeksen R&D Technologies Ltd. | Commercial: Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit | Device ID: 525 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| 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 SA | 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: 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: 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: 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 |
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