Antiserum, Fluorescent, Q Fever
The Q Fever Fluorescent Antiserum is a microbiology diagnostic reagent used in fluorescent antibody tests to identify Coxiella burnetii, the intracellular bacterium responsible for Q fever, a zoonotic infection transmitted from animals to humans. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPJ, regulated under 21 CFR 866.3500 in the Microbiology specialty.
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Basic Information
- Product Code
- GPJ
- Device Class
- FDA class 1
- Regulation Number
- 866.3500
- 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 2 510(k) clearances via K numbers.
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.