Device Recall IVD calibrator

  • Modèle / numéro de série
    Catalog number: "KAI-084C", Lot # "559011"
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States (NY, NJ, and NC).
  • Description du dispositif
    "K-ASSAY CRP (3) Calibrator E". || This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is 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