Skip to content

Histoplasma Mycelial Antigen

by I M, Inc. 510(k)

Active United States

510(k) K760826

Overview

Histoplasma Mycelial Antigen is an antigen device used in microbiology for laboratory testing. It is designed to detect antibodies to Histoplasma capsulatum, a fungus that causes histoplasmosis. The antigen is derived from the mycelial phase of the fungus and is used in serological testing procedures.

The device is supplied as a laboratory reagent and is intended for single-use in diagnostic testing. It is not MRI compatible and should be stored according to manufacturer instructions. The device received FDA 510(k) clearance on November 1, 1976, with product code GMJ, and is classified as Class II under regulation number 866.3320.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760826 Date1 Nov 1976ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GMJ
Device Class
Class II
Regulation
21 CFR Part 866.3320
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from I M, Inc.

See all devices from I M, Inc. →

Questions

  • What is the Histoplasma Mycelial Antigen used for?

    The Histoplasma Mycelial Antigen is a laboratory reagent designed to detect antibodies to Histoplasma capsulatum, a fungus that causes histoplasmosis. It is used in serological testing procedures in microbiology laboratories.

  • How is the Histoplasma Mycelial Antigen supplied?

    The device is supplied as a laboratory reagent and is intended for single-use in diagnostic testing. It should be stored according to the manufacturer's instructions and is not MRI compatible.

  • What is the regulatory status of this device?

    The Histoplasma Mycelial Antigen received FDA 510(k) clearance on November 1, 1976, with product code GMJ. It is classified as Class II under regulation number 866.3320.

  • Is this device reusable or single-use?

    The Histoplasma Mycelial Antigen is intended for single-use in diagnostic testing. After use, it should be disposed of according to laboratory protocols and manufacturer instructions.