Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3375](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3375) → GSB — Antigens, Cf, All, Mycoplasma Spp.

# GSB · Antigens, Cf, All, Mycoplasma Spp.

_Microbiology · 21 CFR 866.3375 · Class 1_

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

## Overview

- **Product Code:** GSB
- **Device Name:** Antigens, Cf, All, Mycoplasma Spp.
- **Regulation:** [21 CFR 866.3375](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3375)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist of Mycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Mycoplasma and provides epidemiological information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection with Mycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.

## Classification Rationale

Class I (general 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K852933](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB/K852933.md) | MYCOPLASMA SPP SEROLOGICAL REAGENTS | Microbix Biosystems, Inc. | Aug 1, 1985 | SESE |
| [K843664](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB/K843664.md) | MYCOPLASMA PNEUMONIAE | Institute Virion , Ltd. | Oct 25, 1984 | SESE |
| [K834338](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB/K834338.md) | MYCOPLASMA PNEUMONIAE CF ANTIGEN | Hillcrest Biologicals | Feb 27, 1984 | SESE |
| [K832132](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB/K832132.md) | SERA-TEK MYCOPLASMA ANTIBODY TEST | Miles Laboratories, Inc. | Sep 20, 1983 | SESE |
| [K802934](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB/K802934.md) | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | Orion Diagnostica, Inc. | Dec 31, 1980 | SESE |

## Top Applicants

- Hillcrest Biologicals — 1 clearance
- Institute Virion , Ltd. — 1 clearance
- Microbix Biosystems, Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Orion Diagnostica, Inc. — 1 clearance

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

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