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AimScreen Fentanyl 42338

by Germaine Laboratories, Inc.

AimScreen Fentanyl 42338 is a fentanyl IVD (FDA Class II) made by Germaine Laboratories, Inc., listed in FDA GUDID since 1 Apr 2024 (UDI-DI 00695684423384), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00695684423384 UDI-DI Date1 Apr 2024ListedStatusListed 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  • Withdrawn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
AimScreen Fentanyl
Generic name
Fentanyl IVD, kit, rapid ICT, clinical
Model / reference
42338
Primary DI / UDI-DI
00695684423384
FDA product code
NGL, DJG
GMDN term
Fentanyl IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fentanyl IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code NGL (Test, Opiates, Over The Counter).

Other devices from Germaine Laboratories, Inc.

See all devices from Germaine Laboratories, Inc. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)