FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
Device Facts
| Record ID | P770001 |
|---|---|
| Device Name | FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) |
| Applicant | Fisher Scientific Co., LLC |
| Product Code | LGB · Microbiology |
| Decision Date | Jul 18, 1979 |
| Decision | APPR |
| Regulation | 21 CFR 866.3290 |
| Device Class | Class 3 |
Regulatory Classification
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.
