Rta Viral Nucleic Acid Isolation Kit (100 Tests)
by RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi
Ref 09029100Model 50 tests/ kit, 100 tests/ kit
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 | Number86989180309029AT 08698918032651 | 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- Withdrawn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/ kit, 100 tests/ kit, 09029100
- Primary DI / UDI-DI
- 08698918032651
- Basic UDI-DI
- 86989180309029AT
- 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
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