Device Recall ENA6 Screen Enzyme Immunoassay Test Kit

  • Modelo / Serial
    Catalog No. 720-230
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.
  • Descripción del producto
    Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" || For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source