Product code NOP— Microbiology
WEST NILE VIRUS IGM CAPTURE ELISA
- Classification name
- Elisa, Antibody, West Nile Virus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3940
- Advisory panel
- Microbiology
- Total cleared
- 10
- First cleared
- Most recent
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.”
Market context for product code NOP
FDA has cleared devices under product code NOP between 2003 and 2016, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2006
- 2004
- 2003
Top applicants under product code NOP
Recent clearances under product code NOP
- K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM)
- K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG)
- K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST
- K041817 — WEST NILE DETECT IGM ELISA
- K041068 — WEST NILE VIRUS IGG INDIRECT ELISA
- K041231 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
- K040854 — WEST NILE VIRUS IGM CAPTURE ELISA
- K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
- K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G
- DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.