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Stat Profile Prime Abg

by Nova Biomedical Corporation 9 variants

Stat Profile Prime Abg (53359) 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 20 Sep 2016 (UDI-DI 00385480533591), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K151982

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385480533591 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151982 Date10 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151982 decided 10 Sep 2015 Active
  • FDA GUDID UDI-DI 00385480533591 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2732-2017 FDA Class II initiated 19 Jun 2017 on shared 510(k) K151982

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K151982
  2. Listed FDA GUDID 00385480533591
  3. Recall initiated FDA recalls Z-2732-2017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stat Profile
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Model / Ref / Catalog
PRIME ABG, 53359
Primary DI / UDI-DI
00385480533591
510(k) Number
FDA product code
JIX
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Cleared under the same submission (K151982)

and 8 more cleared under K151982

Similar devices

Other devices filed under FDA product code JIX (CALIBRATOR, MULTI-ANALYTE MIXTURE).

Other devices from Nova Biomedical Corporation

See all devices from Nova Biomedical Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)