BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KAMIYA BIOMEDICAL COMPANY LLC

    Reg #: 2084025 · FEI: 2084025 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    49
    Establishment Types
    2
    Classifications
    33

    Registration Details

    Registration Name
    KAMIYA BIOMEDICAL COMPANY LLC
    Registration Number
    2084025
    FEI Number
    2084025
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12779 Gateway Dr S
    City
    Tukwila
    State
    WA
    ZIP
    98168
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993281

    Owner / Operator

    Firm Name
    KAMIYA BIOMEDICAL COMPANY LLC
    Operator Number
    9001370
    Address
    12779 GATEWAY DRIVE S
    City
    Tukwila
    State
    WA
    Postal Code
    98168
    Country
    US
    Correspondent
    COLIN GETTY

    Products

    Device Name Product Code
    Igg, Antigen, Antiserum, Control DEW
    Test, Cystatin C NDY
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Alpha-1-Lipoprotein, Antigen, Antiserum, Control DER
    Test, Fibrinogen GIS
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Urinalysis Controls (Assayed And Unassayed) JJW
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Calibrator, Primary JIS
    Ferritin, Antigen, Antiserum, Control DBF
    Alpha-1 Microglobulin, Antigen, Antiserum, Control MGA
    System, Test, Rheumatoid Factor DHR
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Plasma, Coagulation Control GGN
    Radioimmunoassay, Immunoreactive Insulin CFP
    Immunoelectrophoretic, Immunoglobulins, (G, A, M) CFF
    Albumin, Antigen, Antiserum, Control DCF
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL
    Calibrator, Multi-Analyte Mixture JIX
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Transferrin, Antigen, Antiserum, Control DDG
    Assay, Glycosylated Hemoglobin LCP
    Haptoglobin, Antigen, Antiserum, Control DAD
    Factor Xiii A, S, Antigen, Antiserum, Control DBT
    Complement C3, Antigen, Antiserum, Control CZW
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    System, Test, Beta-2-Microglobulin Immunological JZG
    Complement C4, Antigen, Antiserum, Control DBI
    Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
    Prealbumin, Antigen, Antiserum, Control JZJ
    Fibrin Split Products GHH
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP

    Proprietary Names

    K-ASSAY(R) IgG K-ASSAY(R) Cystatin C K-ASSAY(R) Cystatin C Control K-ASSAY(R) Cystatin C Calibrator K-ASSAY(R) Apo AI K-ASSAY(R) Fibrinogen Calibrator K-ASSAY(R) Fibrinogen K-ASSAY(R) ASO/RF/CRP Control K-ASSAY(R) Lp(a) Calibrator K-ASSAY(R) Lp(a) K-ASSAY(R) Ferritin K-ASSAY(R) Ferritin Calibrator K-ASSAY(R) Alpha-1 Microglobulin K-ASSAY(R) Serum/Plasma A1-MG Calibrator K-ASSAY(R) Urine A1-MG Calibrator K-ASSAY(R) RF (Ver.2) K-ASSAY(R) RF Calibrator (Ver.2) K-ASSAY(R) CRP K-ASSAY(R) Insulin K-ASSAY(R) Insulin Calibrator K-ASSAY(R) Liquid ITA Control K-ASSAY(R) Lp(a) Control K-ASSAY(R) IgA K-ASSAY Microalbumin Calibrator K-ASSAY Microalbumin K-ASSAY(R) Alpha-1 AG K-ASSAY(R) Multi-Analyte Calibrator K-ASSAY(R) CRP(3) Calibrator E K-ASSAY(R) CRP(3) Calibrator F K-ASSAY(R) CRP(3) Calibrator D K-ASSAY(R) CRP(3) K-ASSAY (R) D-Dimer Control K-ASSAY CRP (VER.2) K-ASSAY(R) Transferrin K-ASSAY(R) CRP Calibrator K-ASSAY(R) Apo AI/B Calibrator K-ASSAY(R) Haptoglobin K-ASSAY(R) Apo B K-ASSAY (R) Factor XIII Reagent, Calibrator, Control K-ASSAY(R) Complement C3 K-ASSAY(R) IgM K-ASSAY(R) ASO Calibrator K-ASSAY(R) ASO K-ASSAY(R) Complement C4 K-ASSAY(R) Alpha-1 AT K-ASSAY(R) Prealbumin Calibrator K-ASSAY(R) Prealbumin K-ASSAY(R) D-Dimer K-ASSAY(R) D-Dimer Calibrator

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device