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NOP — Elisa, Antibody, West Nile Virus Class II

FDA Device Classification

Classification Details

Product Code
NOP
Device Class
Class II
Regulation Number
866.3940
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153308euroimmun usEUROIMMUN Anti-West Nile Virus ELISA (IgM)August 12, 2016
K153303euroimmun usEUROIMMUN Anti-West Nile Virus ELISA (IgG)August 10, 2016
K052519spectral diagnosticsSPECTRAL WEST NILE VIRUS IGM STATUS TESTNovember 30, 2006
K041817inbios intlWEST NILE DETECT IGM ELISANovember 19, 2004
K041068panbio limitedWEST NILE VIRUS IGG INDIRECT ELISAOctober 20, 2004
K041231panbio limitedWEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02MAugust 10, 2004
K040854focus technologiesWEST NILE VIRUS IGM CAPTURE ELISAJune 30, 2004
K031953focus technologiesWEST NILE VIRUS ELISA IGG, MODEL EL0300GOctober 22, 2003
K031952focus technologiesWEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300MOctober 22, 2003
DEN030004panbio limitedWEST NILE VIRUS IGM CAPTURE ELISAJuly 8, 2003