GMS · Anti-Human Globulin, Fta-Abs Test
Microbiology · 21 CFR 866.3830 · Class 2
Overview
| Product Code | GMS |
|---|---|
| Device Name | Anti-Human Globulin, Fta-Abs Test |
| Regulation | 21 CFR 866.3830 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K853122 | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | Immuno-Products Industries | Sep 19, 1985 | SESE |
| K843613 | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | Immuno-Products Industries | Oct 31, 1984 | SESE |
| K781403 | FTA-ABS TEST SYSTEM | Zeus Scientific, Inc. | Aug 21, 1978 | SESE |
Top Applicants
- Immuno-Products Industries — 2 clearances
- Zeus Scientific, Inc. — 1 clearance
