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Alinity 04U031A

by Abbott

Alinity 04U031A is a medical device (FDA Class I; FDA product code JJE, Analyzer, Chemistry (Photometric, Discrete), for Clinical Use) made by Abbott, listed in FDA GUDID since 24 Jan 2024 (UDI-DI 00380740186289), 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 Number00380740186289 UDI-DI Date24 Jan 2024ListedStatusListed 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  • Withdrawn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
Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Model / Ref / Catalog
04U031A
Primary DI / UDI-DI
00380740186289
FDA product code
JJE
GMDN term
Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Device class
Class I
Regulation number
862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)