← Product Code [GSB](/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB) · K832132

# SERA-TEK MYCOPLASMA ANTIBODY TEST (K832132)

_Miles Laboratories, Inc. · GSB · Sep 20, 1983 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/GSB/K832132

## Device Facts

- **Applicant:** Miles Laboratories, Inc.
- **Product Code:** [GSB](/submissions/MI/subpart-d%E2%80%94serological-reagents/GSB.md)
- **Decision Date:** Sep 20, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3375
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/GSB/K832132](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/GSB/K832132)

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