NOP

Elisa, Antibody, West Nile Virus

Product code: NOP
Device name: Elisa, Antibody, West Nile Virus
Device class: Class 2
21 CFR: 21 CFR 866.3940
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 10 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NOP

Classification and pathway per current FDA publications. Data from openFDA (CC0).