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Alinity 07P8401

by Abbott

Alinity 07P8401 is a Class II device made by Abbott, approved under FDA PMA P080023 on 10 Apr 2009 and listed in FDA GUDID since 11 Oct 2019 (UDI-DI 00380740136635), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P080023

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00380740136635 UDI-DI Date11 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP080023 Date10 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P080023 decided 10 Apr 2009 Active
  • FDA GUDID UDI-DI 00380740136635 listed 11 Oct 2019 Listed

Timeline

2 dated events

  1. Approved FDA PMA P080023
  2. Listed FDA GUDID 00380740136635

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Alinity
Generic name
Hepatitis B virus core total antibody IVD, calibrator
Model / Ref / Catalog
07P8401
Primary DI / UDI-DI
00380740136635
PMA number
FDA product code
LOM
GMDN term
Hepatitis B virus core total antibody IVD, calibrator
Device class
Class II
Regulation number
866.3172
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hepatitis B virus core total antibody IVD, calibrator

Cleared under the same submission (P080023)

and 2 more cleared under P080023

Other devices from Abbott

See all devices from Abbott →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)