GMH · Antiserum, Positive Control, Coccidioides Immitis
Microbiology · 21 CFR 866.3135 · Class 2
Overview
| Product Code | GMH |
|---|---|
| Device Name | Antiserum, Positive Control, Coccidioides Immitis |
| Regulation | 21 CFR 866.3135 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Coccidioides immitis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Coccidioides immitis in serum. The identification aids in the diagnosis of coccidioidomycosis caused by a fungus belonging to the genus Coccidioides and provides epidemiological information on diseases caused by this microorganism. An infection with Coccidioides immitis produces symptoms varying in severity from those accompanying the common cold to those of influenza.
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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K792717 | COCCIDIOIDES IMMITIS, ANTISERUM POS. | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K792688 | COCCIDIOIDES IMMITIS, ANTISERUM | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K792684 | COCCIDIOIDES IMMITIS, ANTISERUM, | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | I M, Inc. | Nov 1, 1976 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 3 clearances
- I M, Inc. — 1 clearance
- Immuno-Mycologics, Inc. — 1 clearance
