KFG · Antiserum, Positive Control, Aspergillus Spp.
Microbiology · 21 CFR 866.3040 · Class 1
Overview
| Product Code | KFG |
|---|---|
| Device Name | Antiserum, Positive Control, 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 |
|---|---|---|---|---|
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Ackrad Laboratories | Jul 1, 1991 | SESE |
| K792698 | ASPERGILLUS SP, ANTISERUM, POSITIVE | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K792686 | ASPERGILLUS SP, ANTISERUM POSITIVE | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | I M, Inc. | Nov 1, 1976 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 2 clearances
- Ackrad Laboratories — 1 clearance
- I M, Inc. — 1 clearance
- Immuno-Mycologics, Inc. — 1 clearance
