FDA product code NOP

Elisa, Antibody, West Nile Virus

Microbiology·Class 2·21 CFR 866.3940
US regulatory classifications
US Product Code (FDA)
NOP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3940
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.

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About this record

Elisa, Antibody, West Nile Virus 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.