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Afinion ACR 1116972

by Abbott Diagnostics Technologies AS

Afinion ACR 1116972 is a Class II device made by Abbott Diagnostics Technologies AS, listed in FDA GUDID since 16 May 2019 (UDI-DI 07070060014630), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07070060014630 UDI-DI Date16 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Afinion ACR
Generic name
Microalbumin IVD, reagent
Model / Ref / Catalog
1116972
Primary DI / UDI-DI
07070060014630
FDA product code
JFY
GMDN term
Microalbumin IVD, reagent
Device class
Class II
Regulation number
862.1225
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microalbumin IVD, reagent

Similar devices

Other devices filed under FDA product code JFY (Enzymatic Method, Creatinine).

Other devices from Abbott Diagnostics Technologies AS

See all devices from Abbott Diagnostics Technologies AS →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)