LGB · Gonococcal Antibody Tests
Microbiology · 21 CFR 866.3290 · Class 3
Overview
| Product Code | LGB |
|---|---|
| Device Name | Gonococcal Antibody Tests |
| Regulation | 21 CFR 866.3290 |
| Device Class | Class 3 |
| Review Panel | Microbiology |
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.
Classification Rationale
Class III (premarket approval) (transitional device).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P770001 | FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) | Fisher Scientific Co., LLC | Jul 18, 1979 | APPR |
Top Applicants
- Fisher Scientific Co., LLC — 1 clearance
