| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Medical Innovation Ventures Sdn Bhd. | Commercial: GenoAmp Real-Time RT-PCR SARS-CoV-2 | Device ID: 275 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Applied Biological Materials Inc | Commercial: GenomeCoV9 Detection Kit | Device ID: 916 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) | Device ID: 1826 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medisys International SA Gmate Covid-19 | Commercial: Gmate Covid-19 | Device ID: 862 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys Co., Ltd. | Commercial: Gmate® COVID-19 Ag Saliva | Device ID: 1854 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime SARS-CoV- (COVID-19) | Device ID: 940 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co., Ltd. | Commercial: Humasis COVID-19 Ag Test | Device ID: 2276 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis | Commercial: Humasis COVID-19 IgG/IgM Test | Device ID: 219 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Device ID: 837 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | 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: Yes | Manufacturer: Imegen | Commercial: Imegen SARS-CoV-2 | Device ID: 789 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Imegen | Commercial: Imegen SARS-CoV-2 plus | Device ID: 1115 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co.,Ltd | Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Device ID: 1844 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) | Device ID: 1845 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Device ID: 224 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co., Ltd | Commercial: Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit | Device ID: 270 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd | Commercial: Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Device ID: 1931 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NanoBio Lab, A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Device ID: 292 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies, Inc. | Commercial: Kaira 2019-nCoV Detection kit | Device ID: 794 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: gerbion GmbH & Co., | Commercial: KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 | Device ID: 567 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KNAX Ltd. | Commercial: KNAX-SMART SARS-CoV-2 IgM/IgG | Device ID: 2537 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KNAX Ltd. | Commercial: KNAX-SMART SARS-CoV2 Influenza A&B Ag combo | Device ID: 2536 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Confirmation RT-Qpcr | Device ID: 511 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Screening RTU RT-qPCR | Device ID: 512 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Device ID: 210 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Chemical Biology and Fundamental Medicine | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Device ID: 223 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: LFA COVID-19 IgG & IgM Rapid Test Device | Device ID: 2186 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Liferiver | Commercial: Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit | Device ID: 260 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) E-gene | Device ID: 409 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) N-gene | Device ID: 408 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) RdRP-gene | Device ID: 410 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Redcliffebio | Commercial: LightPower iVASARS-CoV-2 1st RT-rPCR Kit | Device ID: 824 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: iNtRON Biotechnology Inc | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Device ID: 480 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: intron biotechnology | Commercial: LiliF GBN Covid-19 Ag Rapid kit | Device ID: 2069 | Method: Immunoassay | Target: Antigen | 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: No | Manufacturer: SignalDT Biotechnologies (SZ), Inc | Commercial: LyoDx A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 | Device ID: 373 | Method: RT-PCR | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Corporation | Commercial: Lyra SARS-CoV-2 Assay | Device ID: 331 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ADT Biotech | Commercial: LyteStar 2019-nCoV RT-PCR Kit 1.0 | Device ID: 17 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NESAPOR EUROPA SL | Commercial: MARESKIT | Device ID: 2241 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based) | Device ID: 2355 | Method: | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Spin Column Based) | Device ID: 2347 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Device ID: 580 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: MOLgen SARSCoV2 Real Time RT PCR | Device ID: 508 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Beier Bioengineering Co., Ltd | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Device ID: 58 | 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: Immundiagnostik AG | Commercial: MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit | Device ID: 2014 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: MutaPLEX® CoV-2 MUT real time RT-PCR Kit | Device ID: 1850 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit | Device ID: 582 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: nConV-19 Nucleic Acid qPCR Kit | Device ID: 35 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GeneMatrix Inc | Commercial: NeoPlex COVID-19 Detection Kit | Device ID: 657 | 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