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Afinion™ 2 1116971

by Abbott Diagnostics Technologies AS

Afinion™ 2 1116971 is a Class I device made by Abbott Diagnostics Technologies AS, listed in FDA GUDID since 26 Oct 2023 (UDI-DI 07070060014623), 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 Number07070060014623 UDI-DI Date26 Oct 2023ListedStatusListed 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  • Withdrawn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™ 2
Generic name
Multiple clinical chemistry analyser IVD, point-of-care
Model / Ref / Catalog
1116971
Primary DI / UDI-DI
07070060014623
FDA product code
JQT
GMDN term
Multiple clinical chemistry analyser IVD, point-of-care
Device class
Class I
Regulation number
862.2400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple clinical chemistry analyser IVD, point-of-care

Similar devices

Other devices filed under FDA product code JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica).

Other devices from Abbott Diagnostics Technologies AS

See all devices from Abbott Diagnostics Technologies AS →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)