21 CFR 866.3390 — Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3390
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GTH | Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae | 2 | 3 | 3rd Party |
| GTI | Antisera, Fluorescent, All Groups, N. Meningitidis | 2 | 2 | 3rd Party |
| GTJ | Antisera, All Groups, N. Meningitidis | 2 | 16 | 3rd Party |
| LIC | Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae | 2 | 9 | 3rd Party |
| LIR | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae | 2 | 3 | 3rd Party |
| LSL | Dna-Reagents, Neisseria | 2 | 45 |
