Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3320](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3320) → GMJ — Antigens, Histoplasma Capsulatum, All

# GMJ · Antigens, Histoplasma Capsulatum, All

_Microbiology · 21 CFR 866.3320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ

## Overview

- **Product Code:** GMJ
- **Device Name:** Antigens, Histoplasma Capsulatum, All
- **Regulation:** [21 CFR 866.3320](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3320)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist of Histoplasma capsulatum antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Histoplasma capsulatum from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genus Histoplasma and provides epidemiological information on the diseases caused by this fungus. Histoplasmosis usually is a mild and often asymptomatic respiratory infection, but in a small number of infected individuals the lesions may spread to practically all tissues and organs.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K830837](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K830837.md) | LA-HISTO ANTIBODY SYSTEM #HL 1001 | Immuno-Mycologics, Inc. | May 5, 1983 | SESE |
| [K813359](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K813359.md) | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | American Scientific Products | Dec 31, 1981 | SESE |
| [K802130](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K802130.md) | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | Nolan Biological Laboratories, Inc. | Sep 26, 1980 | SESE |
| [K792701](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K792701.md) | HISTOPLASMA CAPSULATUM, ANTIGEN | Meridian Diagnostics, Inc. | Jan 23, 1980 | SESE |
| [K792711](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K792711.md) | HISTOPLASMA CAPSULATUM, ANTISERUM | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| [K792708](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K792708.md) | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| [K792704](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K792704.md) | HISTOPLASMA CAPSULATUM, ANTIGEN YEAST | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| [K791394](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K791394.md) | HISTOPLASMA MYCELIAL #CF10020X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| [K791393](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K791393.md) | HISTOPLASMA YEAST ANTI #CF10021X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| [K791384](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K791384.md) | FUNGAL IMMUNODIFFUSION KIT #ID1001 | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| [K760827](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K760827.md) | HISTOPLASMA YEAST ANTIGEN | I M, Inc. | Nov 1, 1976 | SESE |
| [K760826](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ/K760826.md) | HISTOPLASMA MYCELIAL ANTIGEN | I M, Inc. | Nov 1, 1976 | SESE |

## Top Applicants

- Immuno-Mycologics, Inc. — 4 clearances
- Meridian Diagnostics, Inc. — 4 clearances
- I M, Inc. — 2 clearances
- American Scientific Products — 1 clearance
- Nolan Biological Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMJ)

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