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ADVIA Centaur® SHBG MCM 10283086

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

4 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 Number00630414551531 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1654-2014 FDA Class II initiated 10 Apr 2014
    • Terminated Z-1653-2014 FDA Class II initiated 10 Apr 2014

    Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

    • Terminated Z-1881-2013 FDA Class II initiated 10 May 2013

    A rare variant of TSH, identified in a small cluster of patients, is not detected.

    • Terminated Z-2313-2012 FDA Class II initiated 25 Jul 2012 on shared 510(k) K083844

    Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA Centaur® SHBG MCM
Generic Name
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
10283086, 6520773
Primary DI / UDI-DI
00630414551531
510(k) Number
FDA Product Code
JLW
GMDN Term
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Device Class
Class II
Regulation Number
862.1690
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K083844)

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