LA-SPORO ANTIBODY SYSTEM
Device Facts
| Record ID | K802427 |
|---|---|
| Device Name | LA-SPORO ANTIBODY SYSTEM |
| Applicant | Immuno-Mycologics, Inc. |
| Product Code | GMA · Microbiology |
| Decision Date | Oct 31, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3680 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Sporothrix schenckii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Sporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis caused by a fungus belonging to the genus Sporothrix and provides epidemiological information on this disease. Sporothrichosis is a chronic tumorlike infection primarily of the skin.
