Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse
Ref VT-STA-25Model Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number5944759080VTSTA25STSMB6Y7 05944759080096 | Date26 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse, VT-STA-25
- Primary DI / UDI-DI
- 05944759080096
- Basic UDI-DI
- 5944759080VTSTA25STSMB6Y7
- Direct Marketing DI
- 05944759080096
- EMDN Code
- W0105090103 Strep. a - rt & poc
- Device Class
- Class B
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- RO-MF-000010877
Other devices from VitroBioChem SRL
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No