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Alinity m 08N45-075

by Abbott Molecular

Alinity m 08N45-075 is a Class II device made by Abbott Molecular, listed in FDA GUDID since 9 Sep 2020 (UDI-DI 00884999047778), 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 Number00884999047778 UDI-DI Date9 Sep 2020ListedStatusListed 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  • Withdrawn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 m
Generic name
HIV1 nucleic acid IVD, calibrator
Model / Ref / Catalog
08N45-075
Primary DI / UDI-DI
00884999047778
FDA product code
MZF
GMDN term
HIV1 nucleic acid IVD, calibrator
Device class
Class II
Regulation number
866.3956
GUDID distribution status
In Commercial Distribution

Related devices

Category: HIV1 nucleic acid IVD, calibrator

Other devices from Abbott Molecular

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Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)