Fluorescent Gonorrhea Test-Heated (FGT-H)

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

GONOCOCCAL ANTIBODY TESTS

PMA Number

P770001 ↗

FDA Product Code

LGB

Device Class

Class III

Regulation

21 CFR Part 866.3290

Advisory Committee

Microbiology

FDA Decision

APPR Approved

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• What is the primary purpose of the FGT-H test?

  The Fluorescent Gonorrhea Test-Heated (FGT-H) is a gonococcal antibody test used to detect specific antibodies, serving as a diagnostic tool within microbiology laboratories.

• Who is the manufacturer of this device?

  The device is manufactured by Fisher Scientific Co., LLC, located in Orangeburg, New York.

• Is this device regulated by the FDA?

  Yes, the device is authorized under FDA PMA (Premarket Approval) number P770001, which indicates it has undergone the regulatory review process for medical devices.