(a)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 toNeisseria 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 withNeisseria gonorrhoeae.
(b)Classification. Class III (premarket approval) (transitional device).
(c)Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]