BEUDAMED
    FDA Registration Active 🇨🇳 China

    GETEIN BIOTECH, INC.

    Reg #: 3009984016 · FEI: 3009984016 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    19

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    Registration Details

    Registration Name
    GETEIN BIOTECH, INC.
    Registration Number
    3009984016
    FEI Number
    3009984016
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.9 Bofu Road, Luhe District,
    City
    Nanjing Jiangsu
    Country
    CN

    Owner / Operator

    Firm Name
    Getein Biotech, Inc.
    Operator Number
    10064252
    Address
    No.9 Bofu Road, Luhe District,
    City
    Nanjing
    State
    Jiangsu
    Postal Code
    211505
    Country
    CN
    Correspondent
    Harry Zhao

    US Agent

    Business Name
    GRZAN GROUP INC.
    Contact Name
    Andy Smith.
    Address
    8825 53 AVE ELMHURST, NY
    City
    Elmhurst
    State
    NY
    ZIP
    11373
    Country
    US
    Email
    [email protected]
    Phone
    332 2015192

    Products

    Device Name Product Code
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Radioimmunoassay, Immunoreactive Insulin CFP
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Radioimmunoassay, Thyroxine-Binding Globulin CEE
    Real Time Nucleic Acid Amplification System OOI
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Calibrator, Multi-Analyte Mixture JIX
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Radioimmunoassay, Progesterone JLS
    Radioimmunoassay, Total Triiodothyronine CDP
    Fluorometer JZT
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Radioimmunoassay, Human Growth Hormone CFL
    Radioimmunoassay, Luteinizing Hormone CEP
    Radioimmunoassay, Estriol CGI
    Radioimmunoassay, Estradiol CHP
    Radioimmunoassay, Total Thyroxine CDX
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Analyzer, Chemistry, Micro, For Clinical Use JJF

    Proprietary Names

    C-Peptide Fast Test Kit (Immunofluorescence Assay) MAGICL C- Peptide (CLIA) MAGICL Insulin (CLIA) Insulin Fast Test Kit(Immunofluorescence Assay) Thyroid function series Multi Control 1 Hormone series Multi Control 1 MAGICL Tg (CLIA) GN 7120 Akso PCR System GN 7000 Akso PCR System MAGICL FSH (CLIA) Composite Calibrator serum Lipid Compound Calibrator MAGICL PRL (CLIA) MAGICL Progesterone (CLIA) T3 Fast Test Kit (Immunofluorescence Assay) MAGICL FT3 (CLIA) MAGICL T3 (CLIA) Getein 1150 Immunofluorescence Quantitative Analyzer T4 Fast Test Kit (Immunofluorescence Assay) MAGICL hGH (CLIA) MAGICL LH (CLIA) MAGICL UE3 (CLIA) MAGICL Estradiol (CLIA) MAGICL T4 (CLIA) Getein 1160 Immunofluorescence Quantitative Analyzer MAGICL 8500 Chemiluminescence Immunoassay Analyzer MAGICL 6200 Chemiluminescence Immunoassay Analyzer CM-1000 Clinical Chemistry Analyzer MAGICL 6000i Chemiluminescence Immunoassay Analyzer Getein 1600 Immunofluorescence Quantitative Analyzer Getein 208 Hand-held Integrated System MAGICL 6000 Chemiluminescence Immunoassay Analyzer Getein 1100 Immunofluorescence Quantitative Analyzer Getein 1200 Immunofluorescence Quantitative Analyzer MAGICL 6800 Chemiluminescence Immunoassay Analyzer Getein 1180 Immunofluorescence Quantitative Analyzer CM-400 Clinical Chemistry Analyzer CM-800 Clinical Chemistry Analyzer

    Establishment Types

    Manufacture Medical Device