ASPERGILLUS MYCELIAL ANTIGEN
Device Facts
| Record ID | K760830 |
|---|---|
| Device Name | ASPERGILLUS MYCELIAL ANTIGEN |
| Applicant | I M, Inc. |
| Product Code | JWT · Microbiology |
| Decision Date | Nov 1, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3040 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies to Aspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the genus Aspergillus. Aspergillosis is a disease marked by inflammatory granulomatous (tumor-like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
