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510(k) K031953

WEST NILE VIRUS ELISA IGG, MODEL EL0300G by Focus Technologies, Inc. — Product Code NOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2003
Date Received
June 25, 2003
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.

Other clearances by Focus Technologies, Inc.

  • K040854 — WEST NILE VIRUS IGM CAPTURE ELISA (June 30, 2004)
  • K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (October 22, 2003)
  • K021486 — HERPESELECT 2 ELISA IGG, MODEL ELO920G (August 1, 2002)
  • K021429 — HERPESELECT 1 ELISA IGG, MODEL EL0910G (July 29, 2002)

Other clearances for product code NOP

  • K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM) (August 12, 2016)
  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 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)
  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)