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Alinity m 09N61-03B

by Abbott Molecular

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884999052062 UDI-DI Date20 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
09N61-03B
Primary DI / UDI-DI
00884999052062
510(k) Number
FDA Product Code
PGI
GMDN Term
Laboratory instrument/analyser application software IVD
Device Class
Class II
Regulation Number
866.3309
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233349)

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No