Alinity 04U261A

Alinity 04U261A is a Class I device made by Abbott, listed in FDA GUDID since 24 Jan 2024 (UDI-DI 00380740186487), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00380740186487 UDI-DI	Date24 Jan 2024Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00380740186487

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Alinity
Generic name: Lactate IVD, kit, spectrophotometry
Model / Ref / Catalog: 04U261A

Primary DI / UDI-DI: 00380740186487
FDA product code: JJE
GMDN term: Lactate IVD, kit, spectrophotometry

Device class: Class I
Regulation number: 862.2160
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Premarket exempt
Lot / batch number

Other properties (12, all answered No)