Biophen Plasma Calibrator 222101
Biophen Plasma Calibrator 222101 is a Class II device made by Hyphen Biomed, cleared under FDA 510(k) K043451 on 17 Mar 2005 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 03663537008252), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03663537008252 | Date25 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043451 | Date17 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 03663537008252
- FDA 510(k) database K043451
Across registries
- FDA 510(k) K043451 decided 17 Mar 2005 Active
- FDA GUDID UDI-DI 03663537008252 listed 25 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K043451
- Listed FDA GUDID 03663537008252
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Biophen Plasma Calibrator
- Generic name
- Plasma protein IVD, calibrator
- Model / Ref / Catalog
- 222101
- Primary DI / UDI-DI
- 03663537008252
- 510(k) Number
- FDA product code
- GGN
- GMDN term
- Plasma protein IVD, calibrator
- Device class
- Class II
- Regulation number
- 864.5425
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Plasma protein IVD, calibrator.