DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA

  • Model / Serial
    UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US. Nationwide
  • Product Description
    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. || Product Usage: || The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
  • Manufacturer Parent Company (2017)
  • Source
    USFDA