CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-2 SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Device ID: 540 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-3 SARS-CoV-2 Direct OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Device ID: 1122 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: Diagnostic Automation, Inc. SARS-CoV-2 RT-PCR Kit | Device ID: 1194 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: Diagnostic Solutions Laboratory | Commercial: COVID-19 Assay | Device ID: 146 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Diagnostics for the Real World Ltd. | Commercial: SAMBA II COVID-19 Test (near-POC NAT) | Device ID: 147 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Nucleic Acid(RT-PCR) | Device ID: 2140 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: Simplexa COVID-19 Direct RT-PCR Kit | Device ID: 471 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Diatech Pharmacogenetics | Commercial: Easy SARS-CoV-2 | Device ID: 843 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Diatherix Eurofins Laboratory | Commercial: SARS-CoV-2 PCR Test | Device ID: 717 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Diatheva SRL | Commercial: COVID-19 PCR DIATHEVA Detection kit | Device ID: 148 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Macurra SARS-CoV-2 PCR Kit | Device ID: 1417 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DNA Research Center Ltd. | Commercial: CBDNA RT-LAMP RAPID TEST | Device ID: 2607 | Method: LAMP | Target: | Format: Manual | Go to details |
CE Marking: No | Manufacturer: DNA Software Inc. | Commercial: Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B | Device ID: 472 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: DNA Xperts Pvt Ltd. | Commercial: FAST RT-PCR KIT, Real time PCR kit for COVID19 detection | Device ID: 542 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: DNA-Technology R&D LLC | Commercial: SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit | Device ID: 1109 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Dotz Nano Ltd. | Commercial: Dotz SARS-CoV-2 Rapid Diagnostic Kit | Device ID: 2927 | Method: LAMP | Target: Nucleic acid | Format: Automated, Fully automated (robot), Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: Novel Coronavirus(2019-nCov)RT-PCR Kit | Device ID: 151 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: COVID-19 Real-time PCR Testing Kit | Device ID: 155 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eiken Chemical Co. Ltd. | Commercial: Loopamp SARS-CoV-2 Detection kit | Device ID: 1638 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Elabscience | Commercial: Novel Coronavirus (SARS-CoV-2) Nucleic Acid Assay Kit (RT-PCR) | Device ID: 546 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 BASIC A RT | Device ID: 548 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 BASIC A500 RT | Device ID: 846 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 CONFIRM RT | Device ID: 847 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: GeneFinder COVID-19 Plus RealAmp Kit | Device ID: 889 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 ELITe MGB® Kit | Device ID: 1861 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based | Go to details |
CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 PLUS ELITe MGB® Kit | Device ID: 1862 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Semi-automated | Go to details |
CE Marking: No | Manufacturer: EMG | Commercial: Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO) | Device ID: 782 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Enbiotech s.r.l | Commercial: SARS-CoV-2 POC | Device ID: 3006 | Method: LAMP | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Ender diagnostics ag | Commercial: ender LAB | Device ID: 1184 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Ender diagnostics ag | Commercial: ender MASS | Device ID: 1183 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eryigit Biomedical Devices | Commercial: Covid-19 qRT PCR Detection Kit | Device ID: 550 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eryigit Biomedical Devices | Commercial: Sentebiolab Senteligo SARS-CoV-2 (COVID-19) Multiplex qPCR Detection Kit | Device ID: 1300 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eset Ltd. | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 956 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Eudipia Co. Ltd. | Commercial: EuDx COVID-19 Detection Kit | Device ID: 848 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 Fast-SVD | Device ID: 2867 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 Multiplex | Device ID: 473 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 SNPs | Device ID: 2275 | Method: RT-PCR | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: EURORealTime SARS-CoV-2 | Device ID: 159 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Exact Sciences | Commercial: SARS-CoV-2 Test | Device ID: 719 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: EXON BIYOMEDIKAL | Commercial: EXON SARS-CoV-2 Real Time PCR Tanı Kiti | Device ID: 1738 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 KIT 1-RQ | Device ID: 2064 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 VRT KIT 2-RQ | Device ID: 2065 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: FAGO MEDÄ°KAL SANAYÄ° TÄ°CARET Ltd. ÅžTÄ°. | Commercial: FAMEX Coronavirus (2019-nCoV) Antigentest | Device ID: 2053 | Method: Immunochromatography | Target: Nucleic acid | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fast Track Diagnostics | Commercial: FTD-114 SARS-CoV-2 (manual & lab-based NAT) | Device ID: 163 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Rapid Home Nucleic Acid Test | Device ID: 165 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: FluroTest LLC | Commercial: CompleTest | Device ID: 553 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Fluxergy Inc. | Commercial: Fluxergy Test Kit COVID-19 | Device ID: 167 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method) | Device ID: 1869 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Variant Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2071 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun FluA/FluB/SC2 qPCR | Device ID: 2719 | Method: | Target: | Format: | 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