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Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers OSR61154

by Fisher Diagnostics

Listed FDA GUDID listing, no authorization on record

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 Number00845275000016 UDI-DI Date18 Nov 2025ListedStatusListed GUDID: 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  • Withdrawn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
Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers
Generic Name
Ammonia IVD, kit, spectrophotometry
Model / Reference
OSR61154
Primary DI / UDI-DI
00845275000016
FDA Product Code
JIF
GMDN Term
Ammonia IVD, kit, spectrophotometry
Device Class
Class I
Regulation Number
862.1065
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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