Rta Viral RNA Isolation Kit (100 Tests)
by RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi
Ref 09010100Model 50 Tests, 100 Tests
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86989180309010A6 08698918032620 | Date12 Jul 2023 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Nucleic Acid Isolation Kit
- Model / Reference
- 50 Tests, 100 Tests, 09010100
- Primary DI / UDI-DI
- 08698918032620
- Basic UDI-DI
- 86989180309010A6
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000021258
From the manufacturer
Manufacturer's product page: Nükleik Asit (DNA/RNA) İzolasyon Kitleri
Other devices from RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No