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Alinity 08P7404

by Abbott Laboratories

Alinity 08P7404 is a multiple-therapy therapeutic drug monitoring IVD (FDA Class II; FDA product code DKB, Calibrators, drug mixture) made by Abbott Laboratories, listed in FDA GUDID since 9 Dec 2019 (UDI-DI 00380740180935), 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 Number00380740180935 UDI-DI Date9 Dec 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  • Withdrawn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
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
08P7404
Primary DI / UDI-DI
00380740180935
FDA product code
DKB
GMDN term
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Device class
Class II
Regulation number
862.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple-therapy therapeutic drug monitoring IVD, calibrator

Similar devices in this category

Other devices filed under Multiple-therapy therapeutic drug monitoring IVD, calibrator.

Other devices from Abbott Laboratories

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Properties

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