Alinity m 09N46-05A

by Abbott Molecular

Alinity m 09N46-05A is a Class II device made by Abbott Molecular, approved under FDA PMA P210022 on 5 May 2022 and listed in FDA GUDID since 19 May 2022 (UDI-DI 00884999049956), 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

FDA submission, from GUDID

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	Number00884999049956 UDI-DI	Date19 May 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMA from GUDID	NumberP210022	Date5 May 2022Issued	StatusActive

Official records

AccessGUDID record UDI-DI 00884999049956
FDA PMA database PMA number P210022

Across registries

2 registries list this device

FDA PMA P210022 decided 5 May 2022 Active
FDA GUDID UDI-DI 00884999049956 listed 19 May 2022 Listed

Timeline

2 dated events

5 May 2022 Approved FDA PMA P210022
19 May 2022 Listed FDA GUDID 00884999049956

Coverage

1 jurisdiction

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Withdrawn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: 09N46-05A

Primary DI / UDI-DI: 00884999049956
PMA number: P210022
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

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Properties

Other properties (15, all answered No)