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510(k) K041817

WEST NILE DETECT IGM ELISA by Inbios Intl., Inc. — Product Code NOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2004
Date Received
July 6, 2004
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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  • K991515 — INSURE PREGNANCY TEST (May 28, 1999)

Other clearances for product code NOP

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  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
  • 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)
  • K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G (October 22, 2003)
  • K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (October 22, 2003)
  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)