Alinity 08P6201
by Abbott
Ref 08P6201
Alinity 08P6201 is a device classified as IVD General (EU), Class II (US) made by Abbott, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00380740151089) and listed in FDA GUDID since 22 Oct 2018 (UDI-DI 00380740151089), active as of 7 Nov 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD EUDAMED | NumberB-00380740151089 00380740151089 | Date2 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00380740151089 | Date22 Oct 2018 | StatusListed |
Official records
- EUDAMED public site B-00380740151089
- AccessGUDID record 00380740151089
Across registries
- EUDAMED Basic UDI-DI B-00380740151089 registered 2 Nov 2026 Active
- FDA GUDID UDI-DI 00380740151089 listed 22 Oct 2018 Listed
Timeline
- Listed FDA GUDID 00380740151089
- Registered EUDAMED B-00380740151089
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Alinity
- Generic name
- Plasma protein IVD, calibrator
- Device name
- Specific Protein Multiconstituent Calibrator
- Model / Ref / Catalog
- 08P6201
- Primary DI / UDI-DI
- 00380740151089
- Basic UDI-DI
- B-00380740151089
- FDA product code
- JIX
- EMDN code
- W0102152203 Specific protein standards and calibrators
- GMDN term
- Plasma protein IVD, calibrator
- Device class
- Class IVD General EUDAMEDClass II GUDID
- Regulation number
- 862.1150
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IVD General | Class II |
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