geneMAP
by Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 55 variants
Ref RV2-RT100
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-TRMF000028405RV2RT100FA D-TRMF000028405RV2RT100FA | Date27 Oct 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- geneMAP Respiratory Viral Panel 2 (2019-nCoV, Inf A/B, RSV A/B),100T
- Model / Reference
- RV2-RT100
- Primary DI / UDI-DI
- D-TRMF000028405RV2RT100FA
- Basic UDI-DI
- B-TRMF000028405RV2RT100FA
- EMDN Code
- W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
- Device Class
- Class IVD General
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000028405
Other devices from Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No