21 CFR 866.3290 — Gonococcal Antibody Tests
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3290
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LGB | Gonococcal Antibody Tests | 3 | 1 |
