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ADVIA® Chemistry AAG a1-Acid Glycoprotein Reagents 10361936

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00630414590158 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA® Chemistry AAG a1-Acid Glycoprotein Reagents
Generic Name
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10361936, 4862129
Description
a1 Acid Glycoprotein - ADVIA Chem. - RGT - 2x100 tests
Primary DI / UDI-DI
00630414590158
FDA Product Code
LKL
GMDN Term
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Device Class
Class I
Regulation Number
866.5420
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Serial Number: No
  • Manufacturing Date: No