Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
The Schistosoma Mansoni Fluorescent Antibody Test Antigen is a parasitology reagent used in indirect fluorescent antibody tests to detect antibodies against Schistosoma mansoni, a blood fluke responsible for intestinal and hepatic schistosomiasis. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNH, regulated under 21 CFR 866.3600 in the Microbiology specialty.
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Basic Information
- Product Code
- GNH
- Device Class
- FDA class 1
- Regulation Number
- 866.3600
- 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 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.