Pure Global
FDA product code GNH

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

Microbiology·Class 1·21 CFR 866.3600
US regulatory classifications
US Product Code (FDA)
GNH
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 866.3600
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Search keywords

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01Schistosoma antigen02Fluorescent antibody03FAT test04Parasite antigen05Schistosomiasis test06Immunoassay07Infectious disease08Diagnostic antigen09Antibody detection10Lab test
About this record

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.