Device Recall Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST KIT

  • Modèle / numéro de série
    Catalog #/Product # BC-1123 Kit lot numbers: RN-27940, 33689, and 37260
  • Classification du dispositif
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
  • Description du dispositif
    Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    BioCheck Inc, 323 Vintage Park Dr, Foster City CA 94404-1186
  • Société-mère du fabricant (2017)
  • Source
    USFDA