Anti-HLA-B27-FITC/Anti-HLA-B7-PE
Ref A07739Model IOTest
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 | Number150995903A07739RM 15099590200534 | Date31 Mar 2023 | 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- Withdrawn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
- IOTest, A07739
- Primary DI / UDI-DI
- 15099590200534
- Basic UDI-DI
- 150995903A07739RM
- EMDN Code
- W0103080699 Reagents for flow cytometry - other
- Device Class
- Class C
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000011121
Other devices from Immunotech SAS
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No