Skip to content

AimStep Flu A&B Test Kit 74425

by Germaine Laboratories, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00695684744250 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AimStep Flu A&B Test Kit
Generic Name
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Model / Reference
74425
Primary DI / UDI-DI
00695684744250
FDA Product Code
PSZ
GMDN Term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
866.3328
GUDID distribution status
In Commercial Distribution

Other devices from Germaine Laboratories, Inc.

See all devices from Germaine Laboratories, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No