Device Recall KAssay(R) MultiAnalyte Calibrator

  • Modèle / numéro de série
    Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica
  • Description du dispositif
    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD || The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Kamiya Biomedical Company, LLC, 12779 Gateway Dr S, Tukwila WA 98168-3308
  • Société-mère du fabricant (2017)
  • Source
    USFDA