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ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents 10341115

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00630414513072 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2471-2023 FDA Class II initiated 10 Jul 2023

    Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

    • Terminated Z-1539-2020 FDA Class II initiated 13 Feb 2020

    Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents
Generic Name
Total bilirubin IVD, kit, spectrophotometry
Model / Ref / Catalog
10341115, 2189346
Description
Bilirubin Total - ADVIA Chem. - RGT - 4x356 tests
Primary DI / UDI-DI
00630414513072
510(k) Number
FDA Product Code
JFM, MQM
GMDN Term
Total bilirubin IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1110, 862.1113
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K063845)

Cleared under the same submission (K170065)

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