CLIA Beta 2 Glycoprotein IgA
by TestLine Clinical Diagnostics s.r.o. EUDAMED
Active
Ref CL-BGA100
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8595635312205BR | Date2 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- CLIA Beta 2 Glycoprotein IgA
- Model / Reference
- CL-BGA100
- Primary DI / UDI-DI
- 08595635312205
- Basic UDI-DI
- 8595635312205BR
- EMDN Code
- W0102100503 Anti-b2-glycoprotein i antibodies
- Device Class
- Class B
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000001803
Other devices from TestLine Clinical Diagnostics s.r.o.
Properties
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No