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ADVIA® Chemistry HAPT Haptoglobin Reagents 10323850

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 Number00630414491356 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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 HAPT Haptoglobin Reagents
Generic Name
Haptoglobin IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10323850, 6149314
Description
Haptoglobin - ADVIA Chem. - RGT - 540 tests
Primary DI / UDI-DI
00630414491356
FDA Product Code
DAD
GMDN Term
Haptoglobin IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
866.5460
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