Manufacturer Profile
KAMIYA BIOMEDICAL COMPANY, LLC Registered Devices
Listing registered devices, PMA filings, and compliance records for KAMIYA BIOMEDICAL COMPANY, LLC.
gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP).
ID: K180C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
ID: K310C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
ID: K310C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C.
ID: K200C-2M
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gudid
For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
ID: KAI-305
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gudid
For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.
ID: KAI-375
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gudid
For the quantitative determination of human rheumatoid factor (RF) in serum and plasma by immunoturbidimetric assay.
ID: KAI-230
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gudid
For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
ID: KAI-301
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gudid
For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
ID: KAI-300
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.
ID: K94C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.
ID: K94C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Insulin.
ID: K73C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Insulin.
ID: K73C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
ID: K284C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
ID: K284C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
ID: K283C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
ID: K283C-2M
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gudid
For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay.
ID: KAI-280
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.
ID: K92C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.
ID: K92C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
ID: K204C-10M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
ID: K135C-10M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K59C-L3
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K59C-L2
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K59C-L1
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K204C-10M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K125C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K125C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].
ID: K114C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].
ID: K114C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K110C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K104C-10M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C.
ID: K100C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C.
ID: K100C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K81C-6M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP).
ID: K80C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for fibrinogen.
ID: K63C-10M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K59C-3M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K55C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K55C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for fructosamine.
ID: K52C-6M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K49C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
ID: K49C-2M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for microalbumin.
ID: K37C-SAM
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for microalbumin.
ID: K37C-4M
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gudid
For use as a consistent test sample of known concentration for monitoring assay conditions for hemoglobin A1c.
ID: K29C-4M
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gudid
For the calibration of the K-ASSAY Alpha-1 AG, Alpha-1 AT, Complement C3, Comlement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin assays.
ID: KAI-016C
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gudid
For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood.
ID: KAI-197
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gudid
For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood.
ID: KAI-196
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gudid
For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.
ID: KAI-160
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gudid
For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.
ID: KAI-105
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gudid
For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay.
ID: KAI-095
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gudid
For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.
ID: KAI-101
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gudid
For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.
ID: KAI-092
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gudid
For the quantitative determination of human D-dimer in plasma or serum by immunoturbidimetric assay.
ID: KAI-090
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gudid
For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.
ID: KAI-082
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gudid
For the quantitative determination of human streptolysin O (ASO) in serum by immunoturbidimetric assay.
ID: KAI-078
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gudid
For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.
ID: KAI-074
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gudid
For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.
ID: KAI-073
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gudid
For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay.
ID: KAI-071
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gudid
For the quantitative determination of human albumin in urine by immunoturbidimetric assay.
ID: KAI-057
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gudid
For the quantitative determination of human alpha-1 microglobulin in urine, serum and plasma by immunoturbidimetric assay.
ID: KAI-056
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gudid
For the quantitative determination of human prealbumin in serum by immunoturbidimetric assay.
ID: KAI-053
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