510(k) K153303

EUROIMMUN Anti-West Nile Virus ELISA (IgG) by Euroimmun Us, Inc. — Product Code NOP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 10, 2016
Date Received: November 16, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Elisa, Antibody, West Nile Virus
Device Class: Class II
Regulation Number: 866.3940
Review Panel: MI
Submission Type

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.

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Other clearances for product code NOP

K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM) (August 12, 2016)
K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
K041817 — WEST NILE DETECT IGM ELISA (November 19, 2004)
K041068 — WEST NILE VIRUS IGG INDIRECT ELISA (October 20, 2004)
K041231 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (August 10, 2004)
K040854 — WEST NILE VIRUS IGM CAPTURE ELISA (June 30, 2004)
K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (October 22, 2003)
K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G (October 22, 2003)
DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)