Stat Profile Prime Abg
by Nova Biomedical Corporation 9 variants
Stat Profile Prime Abg (53655) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K151982 on 10 Sep 2015 and listed in FDA GUDID since 6 Jul 2017 (UDI-DI 00385480536554), 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 | Number00385480536554 | Date6 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151982 | Date10 Sep 2015 | StatusActive |
Official records
- AccessGUDID record 00385480536554
- FDA 510(k) database K151982
Across registries
- FDA 510(k) K151982 decided 10 Sep 2015 Active
- FDA GUDID UDI-DI 00385480536554 listed 6 Jul 2017 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) K151982
- Recall initiated FDA recalls Z-2732-2017
- Listed FDA GUDID 00385480536554
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stat Profile
- Generic name
- Blood gas analyser IVD, point-of-care
- Model / Ref / Catalog
- PRIME ABG, 53655
- Primary DI / UDI-DI
- 00385480536554
- 510(k) Number
- FDA product code
- CHL, JJX, JJS
- GMDN term
- Blood gas analyser IVD, point-of-care
- Device class
- Class II
- Regulation number
- 862.1120, 862.1660
- GUDID distribution status
- In Commercial Distribution
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