| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test Kit | Device ID: 1578 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Asterion Otel Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti. | Commercial: Genenzyme SARS-CoV-2 RT-PCR Kit | Device ID: 2961 | Method: RT-PCR | Target: | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Astra Biotech GmbH | Commercial: SARS-CoV-2 Triplex PCR kit | Device ID: 1132 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atila BioSystems Inc. | Commercial: Atila iAMP COVID-2019 Detection Kit | Device ID: 43 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | Commercial: Atlas COVID-19 Real Time RT-PCR Kit | Device ID: 774 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ä°DÄ°L BÄ°OTECH ARAÅžTIRMA SAN. VE TÄ°C. Ltd. ÅžTÄ°. | Commercial: RevoDx SARS-CoV-2 qPCR Kit | Device ID: 2877 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BAG Diagnostics | Commercial: Viro-Q SARS-CoV-2 kit | Device ID: 703 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Real Time RT-PCR Kit | Device ID: 2738 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD SARS-CoV-2 Reagents for BD MAX System | Device ID: 706 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD SARS-CoV-2/Flu for BD Max Systems | Device ID: 2883 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: ARMS -PCR Detection Kit for SARS-CoV-2 L452R and E484Q mutations | Device ID: 3050 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: ARMS-PCR Detection Kit for 2019-nCoV HV69-70del and N501Y mutation | Device ID: 3049 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Duplex Real-Time PCR Detection Kit for 2019-nCoV ORF1ab/N Gene | Device ID: 3052 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N | Device ID: 3053 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Device ID: 3054 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV (manual & automated lab-based) | Device ID: 57 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens | Device ID: 3055 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiplex Real-Time PCR Detection Kit for 27 Species of Respiratory Pathogens | Device ID: 3056 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Viruses A/B | Device ID: 3057 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip) | Device ID: 61 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 RT-PCR Test Kit | Device ID: 832 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing NaGene Diagnosis Reagent Co. Ltd. | Commercial: Multiple Real-Time PCR kit for Detection of 2019-nCoV | Device ID: 75 | 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: 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: 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: 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: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2/FLU/RSV Panel | Device ID: 2663 | Method: RT-PCR | Target: | Format: Fully automated (robot) | 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: 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: 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: Yes | Manufacturer: bioMérieux SA | Commercial: ARGENE COVID-19 R-GENE | Device ID: 2681 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: bioMerieux | Commercial: ARGENE COVID-19 R-GENE | Device ID: 2757 | Method: RT-PCR | Target: | Format: Manual | 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: BioMol Laboratories srl | Commercial: INFET-002-100 SARS-COV-2 RT-PCR KIT VIRAL 3 | Device ID: 2361 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-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: 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: 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: Yes | Manufacturer: Bioscience(Tianjin) Diagnostic Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Rapid Detection kit | Device ID: 2858 | Method: RT-PCR | Target: Antigen | Format: Near POC / POC | 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 |
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