GMA · Antisera, Fluorescent, Sporothrix Schenekii
Microbiology · 21 CFR 866.3680 · Class 1
Overview
| Product Code | GMA |
|---|---|
| Device Name | Antisera, Fluorescent, Sporothrix Schenekii |
| Regulation | 21 CFR 866.3680 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802427 | LA-SPORO ANTIBODY SYSTEM | Immuno-Mycologics, Inc. | Oct 31, 1980 | SESE |
Top Applicants
- Immuno-Mycologics, Inc. — 1 clearance
