| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 2019-nCoV RT-qPCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: 2019-nCoV qRT-PCR Detection Assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Coyote Bioscience | Commercial: 2019-nCoV Prep Free QPCR Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Beijing Kinhawk Pharmaceutical Co., Ltd | Commercial: 2019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Nucleic Acid Test Kit (PCR- fluorescence probe method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BGI | Commercial: 2019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Nucleic Acid Detection Kit (RT-IMSA Method) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Nucleic Acid Detection Kit (Q-PCR Method) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Anlong Gene Technology Co., Ltd | Commercial: 2019-nCov nucleic acid (Fluorescence PCR) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Dan Wei Biotechnology Co.Ltd | Commercial: 2019-nCoV Direct RT-qPCR Kit | 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 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: 2019 Novel Coronavirus Real-time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Northwell Health | Commercial: 2019 Novel Coronavirus PCR | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangzhou HEAS BioTech Co., Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Anitoa | Commercial: 2019 New Coronavirus (2019-nCoV) Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Centers for Disease Control and Prevention | Commercial: 2019 nCoV Real-Time RT-PCR Diagnostic Panel | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc | Commercial: 1copy COVID-19 qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Spectrum for Diagnostic Industries | Commercial: (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: ViSure transport kit | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Caspr Biotech | Commercial: Ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Total RNA Purification Kit Dx (Dx17200) | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Total Nucleic Acid Preservation Tubes Dx (Cat#Dx69200) | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: No | Manufacturer: University of Washington | Commercial: Tongue swab diagnosis of SARS-CoV-2 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Broad Institute, MIT | Commercial: STOPCovid kit | Method: Other | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Conlight Medical Lab Co., Ltd. | Commercial: SARS-CoV-2/FluA/FluB/RSV detection kit（PCR MALDI-TOF-MS） | Method: Other | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method) | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold) | Method: Other | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vision Medicals | Commercial: SARS-CoV-2 Clinical Sequencing assay | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co., Ltd | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Method: Other | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Saliva/Swab RNA Purification 96-Well Kit Dx (Cat#Dx69300) | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Saliva RNA Collection and Preservation Devices Dx (Cat#53800) | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Saliva / Swab RNA Purification Kit Dx (Cat#Dx69100) | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: RNAsure RNA Extraction Kit | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: RNAsure - Covid-19 RNA Extraction Kit | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Pinpoint Science Inc | Commercial: Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech, Inc | Commercial: pGOLD COVID-19 IgG/IgM/IgA Microarray Test | Method: Other | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PEPperPRINT GmbH | Commercial: PEPperCHIP SARS-CoV-2 Proteome Microarray (manual) | Method: Other | Target: Other | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Integrated Nano-Technologies | Commercial: Palladium | Method: Other | Target: Other | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: NuActor - Viral extraction kit | Method: Other | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Twist Bioscience | Commercial: NGS-based target capture for SARS-CoV-2 detection and screening | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Beijing Infervision Technology Co. Ltd | Commercial: InferRead CT Pneumonia | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: PHARMANONA İLAÇ TIBBİ CİHAZ VE KOZMETİK SANAYİ TİCARET ANONİM ŞİRKETİ. | Commercial: FOAMING TEST | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics Virus Swab Sampling Kit | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 Neutralizing Antibody FIA | Method: Other | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TeraBioSafety Ltd | Commercial: Coronavirus Breath Analyzer | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CanaryQ | Commercial: Collection tools and blood separation for serology diagnostics for SARS-CoV-2 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Paragon Genomics Inc | Commercial: CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fjord Diagnostics SDN | Commercial: BHD SEDIPREP COVID-19 | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Trinity Biotech | Commercial: Bartels FlexTrans Medium | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Ativa Medical | Commercial: Ativa Enhanced Screen | Method: Other | Target: Other | 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