Skip to content

Alinity 04T811A

by Abbott

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.

Overview

Alinity c TPRO2 Assay File is a laboratory instrument/analyser application software designed for use with an incubation control, data processing, display, or communication, and produces raw-data-derived qualitative result calculations based on specified criteria. The software does not use demographic or clinical data to produce a patient score.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00380740186159 UDI-DI Date14 Jun 2022ListedStatusListed 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  • Withdrawn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
Generic name
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
04T811A
Primary DI / UDI-DI
00380740186159
FDA product code
JJE
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class I
Regulation number
862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laboratory instrument/analyser application software IVD

Similar devices in this category

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

Other devices from Abbott

See all devices from Abbott →

Properties

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