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ADVIA Centaur® PHTN Calibrator 10314977

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00630414121772 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0930-2014 FDA Class II initiated 18 Dec 2013
    • Terminated Z-0929-2014 FDA Class II initiated 18 Dec 2013

    ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA Centaur® PHTN Calibrator
Generic Name
Phenytoin therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
10314977, 570404
Primary DI / UDI-DI
00630414121772
510(k) Number
FDA Product Code
DIP
GMDN Term
Phenytoin therapeutic drug monitoring IVD, calibrator
Device Class
Class II
Regulation Number
862.3350
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K011393)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No