Product code NOP
- Device name
- Elisa, Antibody, West Nile Virus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3940
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- 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.
- Source
- FDA openFDA device classification dataset