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510(k) K041231

WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M by Panbio Limited — Product Code NOP

K041231 is an FDA 510(k) premarket notification submitted by Panbio Limited for the device "WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M". The FDA issued a decision of Substantially Equivalent on August 10, 2004. The device falls under product code NOP (Elisa, Antibody, West Nile Virus), a Class II device regulated under 21 CFR 866.3940. Panbio Limited has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2004
Date Received
May 10, 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.

Other clearances by Panbio Limited

  • K041068 — WEST NILE VIRUS IGG INDIRECT ELISA (October 20, 2004)
  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)
  • K030863 — EBV VCA-P18 IGG ELISA (June 27, 2003)

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)
  • 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)

FDA data resources