ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST
Device Facts
| Record ID | K903201 |
|---|---|
| Device Name | ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST |
| Applicant | Gen-Probe, Inc. |
| Product Code | MDC · Microbiology |
| Decision Date | Sep 12, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3060 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
