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ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents 10309507

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

1 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 Number00630414508436 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1653-2016 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  • Withdrawn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 D-HDL Direct HDL Cholesterol Reagents
Generic Name
High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Model / Ref / Catalog
10309507, 7511947
Description
HDL Cholesterol - ADVIA Chem. - RGT - 4x326 tests
Primary DI / UDI-DI
00630414508436
510(k) Number
FDA Product Code
LBS
GMDN Term
High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Device Class
Class I
Regulation Number
862.1475
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K982341)

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