Skip to content

Alinity 08P6318

by Abbott Laboratories

Alinity 08P6318 is a Class I device made by Abbott Laboratories, listed in FDA GUDID since 11 May 2020 (UDI-DI 00380740179373), 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 Number00380740179373 UDI-DI Date11 May 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  • Withdrawn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
Generic name
Multiple drugs of abuse IVD, control
Model / Ref / Catalog
08P6318
Primary DI / UDI-DI
00380740179373
FDA product code
DIF
GMDN term
Multiple drugs of abuse IVD, control
Device class
Class I
Regulation number
862.3280
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Multiple drugs of abuse IVD, control.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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