Kamiya Biomedical Company, LLC

3 devices in the database

  • Model / Serial
    Lot number 418041, catalog number KAI-056.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
  • Product Description
    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. || The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
  • Model / Serial
    Catalog number: "KAI-084C", Lot # "559011"
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States (NY, NJ, and NC).
  • Product Description
    "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.
  • Model / Serial
    Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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