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510(k) Data Aggregation

    K Number
    K162698
    Device Name
    MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
    Manufacturer
    SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD
    Date Cleared
    2017-07-14

    (290 days)

    Product Code
    JLW
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders. The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.
    Device Description
    The MAGLUMI 2000 system is a floor model, fully automated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software. MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(<0.1%) and ProClin® 300; Calibrator Low-TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Calibrator High- TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Buffer- tris buffer, HAMA Blocker, BSA, NaN3(<0.1%) and ProClin® 300; ABEI Label- labeled with anti-TSH monoclonal antibody (mouse), tris buffer, containing BSA, NaN3(<0.1%) and ProClin® 300; Control 1- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 2- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 3- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300.
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