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Alinity 08P1402

by Abbott Ireland

Alinity 08P1402 is a Class II device made by Abbott Ireland, listed in FDA GUDID since 12 Nov 2018 (UDI-DI 00380740136536), 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 Number00380740136536 UDI-DI Date12 Nov 2018ListedStatusListed 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  • Withdrawn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
Folate (vitamin B9) IVD, calibrator
Model / Ref / Catalog
08P1402
Primary DI / UDI-DI
00380740136536
FDA product code
JIT
GMDN term
Folate (vitamin B9) IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Folate (vitamin B9) IVD, calibrator

Similar devices

Other devices filed under FDA product code JIT (Calibrator, secondary).

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

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