| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Beijing Kinhawk Pharmaceutical Co., Ltd | Commercial: 2019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method) | Device ID: 73 | Method: RT-PCR | Target: Nucleic acid | Format: 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: Beijing Savant Biotechnology Co., Ltd | Commercial: Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography) | Device ID: 76 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd | Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) | Device ID: 77 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| 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: No | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Commercial: Wantai SARS-CoV-2 Ab Rapid Test | Device ID: 82 | Method: Immunoassay | Target: Antibody | 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: No | Manufacturer: Bio-Techne | Commercial: Ella / Simple Plex COVID-19 16×4 Standard Panel | Device ID: 85 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | Device ID: 87 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOMAXIMA S.A. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Yes | Manufacturer: BioMedomics, Inc | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 90 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: No | Manufacturer: Biomeme | Commercial: 10 Minutes COVID-19 IgG/IgM Rapid Test | Device ID: 92 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: 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: 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: 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: 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: 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: 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: BluSense Diagnostics ApS | Commercial: ViroTrack Sero COVID-19 IgA+IgM/IgG Ab | Device ID: 103 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: AFIAS COVID-19, Viral Antigen | Device ID: 105 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: Ichroma COVID-19, viral Antigen | Device ID: 107 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Bright Line Research | Commercial: Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test | Device ID: 109 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BTNX Inc | Commercial: Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 110 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: Camtech COVID-19 Rapid Test Kit | Device ID: 111 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Canary Health Technologies | Commercial: AiroStotleCV19 (Breath VOCs) | Device ID: 112 | Method: Other | Target: Other | Format: Other | 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: Yes | Manufacturer: Cellex Inc | Commercial: Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test | Device ID: 116 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: 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: FastRT-qPCR COVID19 detection kit | Device ID: 119 | 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: 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: 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: 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: Confirm Bioscience | Commercial: Instant COVID-19 “Coronavirus” Test | Device ID: 131 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co., Ltd | Commercial: COVID-19 IgM/IgG Ab Test | Device ID: 132 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Coris BioConcept | Commercial: COVID-19 Ag Respi-Strip | Device ID: 133 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: No | Manufacturer: Creative Biolabs | Commercial: SARS-CoV-2 (2019-nCoV) Spike Protein ELISA Kit | Device ID: 135 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Biolabs | Commercial: SARS-CoV-2 (2019-nCoV) Nucleoprotein Protein ELISA Kit | Device ID: 136 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-COV-2 Total Antibody ELISA Kit | Device ID: 137 | Method: ELISA | Target: Antibody | Format: Automated, 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