Device Recall MicroVue CICC1q EIA

  • Modèle / numéro de série
    Lot 051076
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
  • Description du dispositif
    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. || The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Diagnostic Hybrids, Inc., 2005 E State St Ste 100, Athens OH 45701-2125
  • Société-mère du fabricant (2017)
  • Source
    USFDA