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Alinity 04S0002

by Abbott

Alinity 04S0002 is a Class II device made by Abbott, listed in FDA GUDID since 12 Aug 2019 (UDI-DI 00380740153878), 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 Number00380740153878 UDI-DI Date12 Aug 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  • Withdrawn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
Alinity
Generic name
Rheumatoid factor IVD, calibrator
Model / Ref / Catalog
04S0002
Primary DI / UDI-DI
00380740153878
FDA product code
JIT
GMDN term
Rheumatoid factor IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rheumatoid factor IVD, calibrator

Other devices from Abbott

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Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)