Alinity m 08N45-085

by Abbott Molecular

Alinity m 08N45-085 is a Class II device made by Abbott Molecular, listed in FDA GUDID since 9 Sep 2020 (UDI-DI 00884999047785), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00884999047785 UDI-DI	Date9 Sep 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00884999047785

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Alinity m
Generic name: HIV1 nucleic acid IVD, control
Model / Ref / Catalog: 08N45-085

Primary DI / UDI-DI: 00884999047785
FDA product code: MZF
GMDN term: HIV1 nucleic acid IVD, control

Device class: Class II
Regulation number: 866.3956
GUDID distribution status: In Commercial Distribution

Other devices from Abbott Molecular

UroVysion

Class C
Vysis

Class C
VP2000

Class A
PathVysion

IVD General

See all devices from Abbott Molecular →

Properties

Single use
Lot / batch number

Other properties (13, all answered No)