MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
Device Facts
| Record ID | K894224 |
|---|---|
| Device Name | MARDX LYME DISEASE EIA (IGG) TEST SYSTEM |
| Applicant | Mardx Diagnostics, Inc. |
| Product Code | LSR · Microbiology |
| Decision Date | Aug 21, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3830 |
| Device Class | Class 2 |
Regulatory Classification
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.
