Devices

Device Recall IVD calibrator

  • Modelo / Serial
    Catalog number: "KAI-084C", Lot # "559011"
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States (NY, NJ, and NC).
  • Descripción del producto
    "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
    Kamiya Biomedical Company, LLC
  • 1 Event

Fabricante

Kamiya Biomedical Company, LLC
  • Dirección del fabricante
    Kamiya Biomedical Company, LLC, 12779 Gateway Dr S, Tukwila WA 98168-3308
  • Empresa matriz del fabricante (2017)
    Kamiya Biomedical Company Llc
  • Source
    USFDA