Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3135](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3135) → GMI — Antigen, Cf And / Or Id, Coccidioides Immitis

# GMI · Antigen, Cf And / Or Id, Coccidioides Immitis

_Microbiology · 21 CFR 866.3135 · Class 2_

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

## Overview

- **Product Code:** GMI
- **Device Name:** Antigen, Cf And / Or Id, Coccidioides Immitis
- **Regulation:** [21 CFR 866.3135](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3135)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Coccidioides immitis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Coccidioides immitis in serum. The identification aids in the diagnosis of coccidioidomycosis caused by a fungus belonging to the genus Coccidioides and provides epidemiological information on diseases caused by this microorganism. An infection with Coccidioides immitis produces symptoms varying in severity from those accompanying the common cold to those of influenza.

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K894617](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K894617.md) | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL | Schiff & Co. | Oct 31, 1989 | SESE |
| [K812190](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K812190.md) | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | American Scientific Products | Aug 31, 1981 | SESE |
| [K812185](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K812185.md) | FUNGAL IMMUNODIFFUSION SYSTEM | American Scientific Products | Aug 25, 1981 | SESE |
| [K802129](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K802129.md) | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | Nolan Biological Laboratories, Inc. | Sep 26, 1980 | SESE |
| [K792716](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K792716.md) | CANDIDA ALBICANS, ANTIGEN | Meridian Diagnostics, Inc. | Jan 24, 1980 | SESE |
| [K792713](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K792713.md) | CANDIDA ALBICANS, ANTISERUM | Meridian Diagnostics, Inc. | Jan 23, 1980 | SESE |
| [K792689](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K792689.md) | COCCIDIOIDES IMMITIS, ANTIGEN | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| [K792682](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K792682.md) | COCCIDIOIDES IMMITIS, ANTIGEN | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| [K791389](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K791389.md) | COCCIDIOIDES ANTIGEN #CF10023X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| [K791383](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K791383.md) | CANDIDA IMMUNODIFFUSION KIT #CA1001 | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| [K770527](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI/K770527.md) | CANDIDA IMMUNODIFFUSION KIT | I M, Inc. | Mar 17, 1978 | SESE |

## Top Applicants

- Meridian Diagnostics, Inc. — 4 clearances
- American Scientific Products — 2 clearances
- Immuno-Mycologics, Inc. — 2 clearances
- I M, Inc. — 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/GMI](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMI)

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