Antiserum, Positive Control, Coccidioides Immitis
The Coccidioides Immitis Positive Control Antiserum is a reference reagent used in laboratory tests to verify the performance of serological assays for detecting Coccidioides immitis, the causative agent of coccidioidomycosis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMH, regulated under 21 CFR 866.3135 in the Microbiology specialty.
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Basic Information
- Product Code
- GMH
- 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 |
|---|---|---|---|---|
| K792717 | COCCIDIOIDES IMMITIS, ANTISERUM POS. | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792688 | COCCIDIOIDES IMMITIS, ANTISERUM | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792684 | COCCIDIOIDES IMMITIS, ANTISERUM, | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | 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.