21 CFR 866.3830 — Sera, Reactive And Non-Specific Control, Fta-Abs Test
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3830
Identification
Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GMR | Sera, Reactive And Non-Specific Control, Fta-Abs Test | 2 | 0 | 3rd Party |
| GMS | Anti-Human Globulin, Fta-Abs Test | 2 | 3 | 3rd Party |
| GMT | Antigens, Ha, Treponema Pallidum | 2 | 9 | 3rd Party |
| GMW | Test, Sorbent, Fta-Abs | 2 | 0 | 3rd Party |
| GMX | Antisera, Fluorescent Antibody For Fta-Abs Test | 2 | 0 | 3rd Party |
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | 4 | 3rd Party |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | 35 | |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 111 | |
| MYR | Test, Donor, Syphilis, Antigens, Treponemal | 2 | 0 |
