Elisa, Antibody, West Nile Virus

NOP · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3940

Classification

FDA Product Code: NOP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3940
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 10
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown