Antigen, Latex Agglutination, Coccidioides Immitis
The Latex Agglutination Antigen for Coccidioides Immitis is a serological reagent used in the diagnosis of coccidioidomycosis (Valley Fever), a fungal infection caused by Coccidioides immitis, through latex agglutination test methods. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMG, regulated under 21 CFR 866.3135 in the Microbiology specialty.
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Basic Information
- Product Code
- GMG
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K812189 | COCCIDIOIDES LATEX AGGLUTINATION | Aug 25, 1981 | Substantially Equivalent | American Scientific Products |
| K792690 | COCCIDIOIDES IMMITIS, LATEX AGGLUTI | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791381 | COCCIDIODES (COCCI) | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K782070 | REAGENT, COCCI LATEX | Feb 01, 1979 | Substantially Equivalent | I M, Inc. |
| K760829 | COCCIDIOIDES MYCELIAL ANTIGEN | Nov 01, 1976 | 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.