← Product Code [LGB](/submissions/MI/subpart-d%E2%80%94serological-reagents/LGB) · P770001

# FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001)

_Fisher Scientific Co., LLC · LGB · Jul 18, 1979 · Microbiology · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/MICROBIOLOGY/subpart-d%E2%80%94serological-reagents/LGB/P770001

## Device Facts

- **Applicant:** Fisher Scientific Co., LLC
- **Product Code:** [LGB](/submissions/MI/subpart-d%E2%80%94serological-reagents/LGB.md)
- **Decision Date:** Jul 18, 1979
- **Decision:** APPR
- **Regulation:** 21 CFR 866.3290
- **Device Class:** Class 3
- **Review Panel:** Microbiology

## Regulatory Identification

A gonococcal antibody test (GAT) is an in vitro device that consists of the reagents intended to identify by immunochemical techniques, such as latex agglutination, indirect fluorescent antibody, or radioimmunoassay, antibodies to Neisseria gonorrhoeae in sera of asymptomatic females at low risk of infection. Identification of antibodies with this device may indicate past or present infection of the patient with Neisseria gonorrhoeae.

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**Source:** [https://fda.innolitics.com/submissions/MICROBIOLOGY/subpart-d%E2%80%94serological-reagents/LGB/P770001](https://fda.innolitics.com/submissions/MICROBIOLOGY/subpart-d%E2%80%94serological-reagents/LGB/P770001)

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