JWT · Antigen, Cf, Aspergillus Spp.
Microbiology · 21 CFR 866.3040 · Class 1
Overview
| Product Code | JWT |
|---|---|
| Device Name | Antigen, Cf, Aspergillus Spp. |
| Regulation | 21 CFR 866.3040 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K812740 | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | Nolan Biological Laboratories, Inc. | Oct 20, 1981 | SESE |
| K792700 | ASPERGILLUS SP, COMPLEMENT FIXATION | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K790672 | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU | Diagnostica, Inc. | May 31, 1979 | SESE |
| K760830 | ASPERGILLUS MYCELIAL ANTIGEN | I M, Inc. | Nov 1, 1976 | SESE |
Top Applicants
- Diagnostica, Inc. — 1 clearance
- I M, Inc. — 1 clearance
- Immuno-Mycologics, Inc. — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
- Nolan Biological Laboratories, Inc. — 1 clearance
