Stat Profile Prime
by Nova Biomedical Corporation 9 variants
Stat Profile Prime (42043) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K141907 on 29 May 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480420433), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385480420433 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141907 | Date29 May 2015 | StatusActive |
Official records
- AccessGUDID record 00385480420433
- FDA 510(k) database K141907
Across registries
- FDA 510(k) K141907 decided 29 May 2015 Active
- FDA GUDID UDI-DI 00385480420433 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-2732-2017
Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.
Timeline
- Cleared FDA 510(k) K141907
- Listed FDA GUDID 00385480420433
- Recall initiated FDA recalls Z-2732-2017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stat Profile
- Generic name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Model / Ref / Catalog
- PRIME, 42043
- Primary DI / UDI-DI
- 00385480420433
- 510(k) Number
- FDA product code
- CEM, KHP, JGS, JFP, JIX, CHL, CGZ, JJS, CGA, GKF
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1600, 862.1450, 862.1665, 862.1145, 862.1150, 862.1120, 862.1170, 862.1660, 862.1345, 864.5600
- GUDID distribution status
- In Commercial Distribution
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