Alinity
Ref 09P4674
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 | Number038074ACP0946JC 00380740173524 | Date23 Aug 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- Withdrawn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
- Device Name
- Alinity c Apolipoprotein A1
- Model / Reference
- 09P4674
- Primary DI / UDI-DI
- 00380740173524
- Basic UDI-DI
- 038074ACP0946JC
- EMDN Code
- W0102010401 Apolipoprotein a i
- Device Class
- Class B
Manufacturer details
- EUDAMED SRN
- DE-MF-000009455
Other devices from ABBOTT GmbH
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No