KFH · Antiserum, Positive Control, Blastomyces Dermatitidis
Microbiology · 21 CFR 866.3060 · Class 2
Overview
| Product Code | KFH |
|---|---|
| Device Name | Antiserum, Positive Control, Blastomyces Dermatitidis |
| Regulation | 21 CFR 866.3060 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Blastomyces dermatitidis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Blastomyces determatitidis in serum. The identification aids in the diagnosis of blastomycosis caused by the fungus Blastomyces dermatitidis. Blastomycosis is a chronic granulomatous (tumor-like) disease, which may be limited to the skin or lung or may be widely disseminated in the body resulting in lesions of the bones, liver, spleen, and kidneys.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | Immuno-Mycologics, Inc. | Feb 24, 1988 | SESE |
| K792685 | BLASTOMYCES DERMATITIDIS, ANTISERUM | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K792681 | BLASTOMYCES DERMATITIDIS POS/CONTROL | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K760833 | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) | I M, Inc. | Nov 1, 1976 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 2 clearances
- I M, Inc. — 1 clearance
- Immuno-Mycologics, Inc. — 1 clearance
