Devices

West Nile Virus IgG DxSelect

  • Model / Serial
    Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
  • Product Description
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G || Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen || Wells, Catalog Number EL0351, Lot Number 121117. || 510(k) No. K031953 || The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event

Manufacturer

Focus Diagnostics Inc
  • Manufacturer Address
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

West Nile Virus IgG DxSelect kit (EL0300G)
  • Model / Serial
  • Product Description
    In-vitro diagnostics - microbiological products
  • Manufacturer
    Focus Diagnostics
WEST NILE VIRUS IGG DXSELECT TEST KIT
  • Model / Serial
    Model Catalog: EL0300G (Lot serial: 122155); Model Catalog: EL0351 (Lot serial: 121117); Model Catalog: EL0300G (Lot serial: 121117); Model Catalog: EL0351 (Lot serial: 122641); Model Catalog: EL0300G (Lot serial: 122641); Model Catalog: EL0351 (Lot serial: 122155)
  • Product Description
    West Nile Virus IgG DxSelect kit
  • Manufacturer
    BIO NUCLEAR DIAGNOSTICS INC.