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  • 注册信息汇总表 Ce 2023.04

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    The document lists 62 in vitro diagnostic medical devices, their English names and abbreviations, IVDR classification, and notes. The devices are microfluidic fluorescent immunoassay kits for measuring various biomarkers, hormones, vitamins, and cardiac/inflammatory markers. The kits are classified between Class B and C under the IVDR regulation. It also lists two automated fluorescent immunoassay analyzers as Class A devices.

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    The document lists 62 in vitro diagnostic medical devices, their English names and abbreviations, IVDR classification, and notes. The devices are microfluidic fluorescent immunoassay kits for measuring various biomarkers, hormones, vitamins, and cardiac/inflammatory markers. The kits are classified between Class B and C under the IVDR regulation. It also lists two automated fluorescent immunoassay analyzers as Class A devices.

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    5 views1 page

    注册信息汇总表 Ce 2023.04

    Uploaded by

    hzfrankshan
    The document lists 62 in vitro diagnostic medical devices, their English names and abbreviations, IVDR classification, and notes. The devices are microfluidic fluorescent immunoassay kits for measuring various biomarkers, hormones, vitamins, and cardiac/inflammatory markers. The kits are classified between Class B and C under the IVDR regulation. It also lists two automated fluorescent immunoassay analyzers as Class A devices.

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    优先级 序号 产品英文全称 产品英文简称 IVDR分类 备注

    1 Thyroid Stimulating Hormone Kit (Microfluidic Fluorescent Immunoassay) LYOFIA TSH Class B
    2 Total Triiodothyronine Kit (Microfluidic Fluorescent Immunoassay) LYOFIA TT3 Class B
    3 Total Thyroxine Kit (Microfluidic Fluorescent Immunoassay) LYOFIA TT4 Class B
    4 Follicle Stimulating Hormone Kit (Microfluidic Fluorescent Immunoassay) LYOFIA FSH Class B
    5 Luteinizing Hormone Kit (Microfluidic Fluorescent Immunoassay) LYOFIA LH Class B
    6 Estradiol Kit (Microfluidic Fluorescent Immunoassay) LYOFIA E2 Class B
    7 Progesterone Kit (Microfluidic Fluorescent Immunoassay) LYOFIA Progesterone Class B
    8 Testosterone Kit (Microfluidic Fluorescent Immunoassay) LYOFIA Testosterone Class B
    9 Prolactin Kit (Microfluidic Fluorescent Immunoassay) LYOFIA Prolactin Class B
    11 Glycated Haemoglobin Kit (Microfluidic Fluorescent Immunoassay) LYOFIA HbA1c Class C
    12 Vitamin B12 Kit (Microfluidic Fluorescent Immunoassay) LYOFIA Vitamin B12 Class B
    第一批
    13 25-hydroxy Vitamin D Kit (Microfluidic Fluorescent Immunoassay) LYOFIA 25-OH Vitamin D Class B
    14 Folate Kit (Microfluidic Fluorescent Immunoassay) LYOFIA Folate Class B
    15 Ferritin Kit (Microfluidic Fluorescent Immunoassay) LYOFIA Ferritin Class B
    16 Serum Amyloid A Kit (Microfluidic Fluorescent Immunoassay) LYOFIA SAA Class B
    17 C-Reactive Protein Kit (Microfluidic Fluorescent Immunoassay) LYOFIA CRP Class B 急性CRP Class C
    18 Procalcitonin Kit (Microfluidic Fluorescent Immunoassay) LYOFIA PCT Class B
    22 High Sensitive Cardiac Troponin I Kit (Microfluidic Fluorescent Immunoassay) LYOFIA hs-cTnI Class C
    24 D-dimer Kit (Microfluidic Fluorescent Immunoassay) LYOFIA D-dimer Class C
    25 B-type Natriuretic Protein Kit (Microfluidic Fluorescent Immunoassay) LYOFIA BNP Class C
    26 N-terminal proBNP Kit (Microfluidic Fluorescent Immunoassay) LYOFIA NT-proBNP Class C
    27 DISKFLU Multiple Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay) DISKFLU HL-8 Class C
    37 Human Chorionic Gonadotropin Beta-subunit Kit (Microfluidic Fluorescent Immunoassay) LYOFIA β-HCG Class B
    38 Human Growth Hormone Kit (Microfluidic Fluorescent Immunoassay) LYOFIA GH Class B

    第三批 45 Insulin-like Growth Factor Binding Protein 1 Kit (Microfluidic Fluorescent Immunoassay) LYOFIA IGFBP-1 Class C

    46 Insulin-like Growth Factor Binding Protein 3 Kit (Microfluidic Fluorescent Immunoassay) LYOFIA IGFBP-3 Class C

    62 Automated Fluorescent Immunoassay Analyzer DISKFLU Class A


    仪器
    63 Fluorescent Immunoassay Analyzer LYOFIA-I、LYOFIA8 Class A

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