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Alinity m 09N46-05B

by Abbott Molecular

Alinity m 09N46-05B is a Class II device made by Abbott Molecular, approved under FDA PMA P210022 on 5 May 2022 and listed in FDA GUDID since 22 Feb 2024 (UDI-DI 00884999051065), 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 P210022

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 Number00884999051065 UDI-DI Date22 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMA from GUDID NumberP210022 Date5 May 2022IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P210022 decided 5 May 2022 Active
  • FDA GUDID UDI-DI 00884999051065 listed 22 Feb 2024 Listed

Timeline

2 dated events

  1. Approved FDA PMA P210022
  2. Listed FDA GUDID 00884999051065

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Alinity m
Generic name
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
09N46-05B
Primary DI / UDI-DI
00884999051065
PMA number
FDA product code
PAB
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class II
Regulation number
866.3180
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laboratory instrument/analyser application software IVD

Cleared under the same submission (P210022)

Similar devices in this category

Other devices filed under Laboratory instrument/analyser application software IVD.

Other devices from Abbott Molecular

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Properties

  • Prescription use
Other properties (14, all answered No)