BEUDAMED
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    ox-LDL ELISA

    FDA UDI
    Immundiagnostik AG·04050598010437·

    AU

    FDA UDI
    Beckman Coulter, Inc.·15099590020361·LDL-Cholesterol

    Synermed®

    FDA UDI
    INFRARED LABORATORY SYSTEMS LLC·05060500090838·HDL-Cholesterol Reagent 1 X 25 mL + 1 X 8.4 mL

    Synermed®

    FDA UDI
    INFRARED LABORATORY SYSTEMS LLC·05060500090814·HDL-Cholesterol Reagent 1 X 240 mL + 1 X 80 mL

    Synermed®

    FDA UDI
    INFRARED LABORATORY SYSTEMS LLC·05060500091989·HDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL

    LDL Cholesterol Reagent

    FDA registration
    SANZAY CORPORATION -·2 products·🇺🇸 United States

    CardioChek Plus Lipid+eGLU Test Strips Smart Bundle Pack

    FDA registration
    Polymer Technology Systems·3 products·🇺🇸 United States

    IR059 Synermed LDL-Cholesterol Reagent

    FDA registration
    Infrared Laboratory Systems dba SYNERMED·2 products·🇺🇸 United States

    Mission Cholesterol Meter

    FDA registration
    ACON LABORATORIES, INC.·3 products·🇺🇸 United States

    Cardiochek Bioscanner plus

    FDA registration
    East West Wisconsin·3 products·🇺🇸 United States

    CardioChek Plus Analyzer

    FDA registration
    Polymer Technology Systems·3 products·🇺🇸 United States

    Discover Plus

    FDA registration
    AMERICAN SCREENING CORPORATION·3 products·🇺🇸 United States

    HDL-LDL Cholesterol Calibrator

    FDA registration
    Diazyme Laboratories, Inc.·2 products·🇺🇸 United States

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Dimension Vista® Testosterone Calibrator

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414948775·Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x ...

    HDL Direct Reagent and Calibrator

    FDA registration
    CLINIQA CORPORATION·2 products·🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667

    FDA UDI
    CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302022667·LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests

    PTS PANELS Metabolic Chemistry Panel Test Strips

    FDA registration
    Polymer Technology Systems·6 products·🇺🇸 United States

    Bialex Glucose Oxidase

    FDA registration
    BIALEX LAB·6 products·🇺🇸 United States

    OCTOPUS

    Device
    EU MDR · Eu Md Class 1 ·Substrate HD·On the market·2 countries