Skip to content

ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) 10335869

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

5 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 Number00630414526690 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2283-2020 FDA Class II initiated 4 May 2020
    • Terminated Z-2282-2020 FDA Class II initiated 4 May 2020

    The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

  • 2 recalls, same reason

    • Terminated Z-1230-2020 FDA Class II initiated 18 Dec 2019
    • Terminated Z-1231-2020 FDA Class II initiated 18 Dec 2019

    There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

    • Terminated Z-1654-2016 FDA Class II initiated 17 Mar 2016

    Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic)
Generic Name
Creatinine IVD, kit, spectrophotometry
Model / Ref / Catalog
10335869, 4992596
Description
Creatinine enzymatic - ADVIA Chem. - RGT - 4x350 tests
Primary DI / UDI-DI
00630414526690
510(k) Number
FDA Product Code
JFY
GMDN Term
Creatinine IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1225
GUDID distribution status
Not in Commercial Distribution

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