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Alinity 07P6010

by Abbott

Alinity 07P6010 is a Class I device made by Abbott, listed in FDA GUDID since 11 Jul 2018 (UDI-DI 00380740121631), 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 Number00380740121631 UDI-DI Date11 Jul 2018ListedStatusListed 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  • Withdrawn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
Treponema pallidum total antibody IVD, control
Model / Ref / Catalog
07P6010
Primary DI / UDI-DI
00380740121631
FDA product code
JJX
GMDN term
Treponema pallidum total antibody IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JJX (Single (specified) analyte controls (assayed and unassayed)).

Other devices from Abbott

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Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)