Antigen, Cf And / Or Id, Coccidioides Immitis
The Coccidioides Immitis CF and/or ID Antigen is a microbiology reagent used in complement fixation (CF) and immunodiffusion (ID) serological tests to detect antibodies against Coccidioides immitis, supporting the diagnosis of coccidioidomycosis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMI, regulated under 21 CFR 866.3135 in the Microbiology specialty.
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Basic Information
- Product Code
- GMI
- Device Class
- FDA class 2
- Regulation Number
- 866.3135
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894617 | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL | Oct 31, 1989 | Substantially Equivalent | Schiff & Co. |
| K812190 | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | Aug 31, 1981 | Substantially Equivalent | American Scientific Products |
| K812185 | FUNGAL IMMUNODIFFUSION SYSTEM | Aug 25, 1981 | Substantially Equivalent | American Scientific Products |
| K802129 | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | Sep 26, 1980 | Substantially Equivalent | Nolan Biological Laboratories, Inc. |
| K792716 | CANDIDA ALBICANS, ANTIGEN | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792713 | CANDIDA ALBICANS, ANTISERUM | Jan 23, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792689 | COCCIDIOIDES IMMITIS, ANTIGEN | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792682 | COCCIDIOIDES IMMITIS, ANTIGEN | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791389 | COCCIDIOIDES ANTIGEN #CF10023X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K791383 | CANDIDA IMMUNODIFFUSION KIT #CA1001 | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K770527 | CANDIDA IMMUNODIFFUSION KIT | Mar 17, 1978 | Substantially Equivalent | I M, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.