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StrepAim 75525

by Germaine Laboratories, Inc.

StrepAim 75525 is a Class I device made by Germaine Laboratories, Inc., listed in FDA GUDID since 17 Jan 2023 (UDI-DI 00695684755256), 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 Number00695684755256 UDI-DI Date17 Jan 2023ListedStatusListed 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  • Withdrawn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
StrepAim
Generic name
Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
Model / reference
75525
Primary DI / UDI-DI
00695684755256
FDA product code
GTY
GMDN term
Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class I
Regulation number
866.3740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices

Other devices filed under FDA product code GTY (Antigens, All Groups, Streptococcus Spp.).

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
  • Manufacturing date
Other properties (9, all answered No)