BEUDAMED
    FDA Registration Active 🇨🇳 China

    JINAN BABIO BIOTECHNOLOGY CO.,LTD.

    Reg #: 3016741564 · FEI: 3016741564 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    43
    Establishment Types
    2
    Classifications
    25

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    Registration Details

    Registration Name
    JINAN BABIO BIOTECHNOLOGY CO.,LTD.
    Registration Number
    3016741564
    FEI Number
    3016741564
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone
    City
    Jinan City Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K250205

    Owner / Operator

    Firm Name
    JINAN BABIO BIOTECHNOLOGY CO.,LTD.
    Operator Number
    10066753
    Address
    303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone
    City
    Jinan City
    State
    Shandong
    Postal Code
    250101
    Country
    CN
    Correspondent
    Xiaotong Zhou

    US Agent

    Business Name
    ABMED MEDICAL TECHNOLOGY INC
    Contact Name
    hui hong
    Address
    800 East Wishkah Street, 1021 Aberdeen,
    City
    Aberdeen
    State
    WA
    ZIP
    98520
    Country
    US
    Email
    [email protected]
    Phone
    509 5816099

    Products

    Device Name Product Code
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Hematoxylin HYJ
    Container, Specimen, Non-Sterile NNI
    Oil, Clearing IJZ
    Culture Media, Non-Selective And Differential JSH
    Giemsa Stain HYF
    Iodine, Grams HYI
    Container, Specimen Mailer And Storage, Sterile KDT
    Culture Media, Selective And Non-Differential JSJ
    Applicator, Absorbent Tipped, Sterile KXG
    Stain, Papanicolau HZJ
    Saline, Vascular Access Flush NGT
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    General Purpose Reagent PPM
    Kit, Mycoplasma Detection KIW
    Eosin Y HYB
    Stain, Reticulocyte GJH
    Transport Medium, Notified Per The Vtm Guidance QMC
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Culture Media, Enriched KZI
    Culture Media, Non-Selective And Non-Differential JSG
    Fluid, Bouin'S IGN
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Block, Heating JRG
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    Modified Cary-Blair Transport Media Cary-Blair Transport Media Hematoxylin eosin staining solution kit Liquid Amies Media Virus Transport Kit (Non-Inactivated) Viral Transport Tube Premium oil mirror oil XLD Agar Medium Thiosulfate Citrate Bile Salts Sucrose Agar Medium Salmonella Shigella Agar Intestinal bacteria agar medium Liu's Dye Solution Kit Jimsa Dye Solution Kit Reichs-Giemsa Dye Solution Rapid Gram dye solution kit Acid fast staining solution kit Acid fast staining solution (fluorescence method) kit Sabouraud Dextrose Agar Medium(SDA) MacConkey Agar Sabouraud Agar Medium Disposable Sampling Swab (Sterile) Disposable Sampling Swab Pap staining solution kit Normal Saline Vaginal microbiome detection kit (dry chemical method) Potato Dextrose AGAR Medium (PDA) Mold Detection Plate Mycoplasma Pneumoniae lgM Test Kit (Colloidal Gold) Reticulocyte staining solution kit Babio® Virus Transport Kit (Non-Inactivated) Virus Transport Kit (Inactivated) Columbia Blood Agar Medium Transport medium Disposable Sampling Swab Regular Swab with Amies Agar Gel Medium Mueller-Hinton Agar Dehydrated Culture Media Lecithin Tween Tryptone Soy Agar Medium Tissue fixative Swab Disposable Sampling Swab (Non-Sterile) Microbial sample pretreatment system (ET-800+) Sample treatment and Incubation System (T-80) Babio® Virus Transport Kit (Non-inactivating)

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device