21 CFR 866.3290
§ 866.3290 Gonococcal antibody test (GAT).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.3290, § 866.3290 Gonococcal antibody test (GAT), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89517
- Permanent ID
ys:prov:89517@1- SHA-256
db6ad44d1005d69b03d49817512b179a0ea9b1fdf904b2573f57c0b1b817ac89
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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 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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.