Devices

KASSAY

  • Model / Serial
    Lot No.: 666011 EXP.: 07/2007
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Kits were distributed to laboratories nationwide. One foreign account in Singapore.
  • Product Description
    K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.
  • Manufacturer
    Kamiya Biomedical Company
  • 1 Event

Manufacturer

Kamiya Biomedical Company
  • Manufacturer Address
    Kamiya Biomedical Company, 12779 Gateway Dr., Seattle WA 98168
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall KAssay(R) MultiAnalyte Calibrator
  • Model / Serial
    Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
  • Manufacturer
    Kamiya Biomedical Company, LLC
Device Recall KAssay
  • Model / Serial
    Lot D407
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI.
  • Product Description
    K-Assay Lp(a) Control
  • Manufacturer
    Kamiya Biomedical Company
KASSAY Alpha1 Microglobulin Reagent
  • Model / Serial
    Lot number 418041, catalog number KAI-056.
  • Product Classification
    Immunology and Microbiology Devices
  • 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...".
  • Manufacturer
    Kamiya Biomedical Company, LLC