BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZHEJIANG GENE SCIENCE CO., LTD

    Reg #: 3016764932 · FEI: 3016764932 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    31

    Registration Details

    Registration Name
    ZHEJIANG GENE SCIENCE CO., LTD
    Registration Number
    3016764932
    FEI Number
    3016764932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    no. 2 workshop, pharmaceutical industrial park, no. 11 shengxing road, shangyu economic and technological dev
    City
    shaoxing Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212878

    Owner / Operator

    Firm Name
    Zhejiang GENE SCIENCE Co., Ltd
    Operator Number
    10071254
    Address
    no. 2 workshop, pharmaceutical industrial park, no. 11 shengxing road, shangyu economic and technological dev
    City
    shaoxing
    State
    Zhejiang
    Postal Code
    312300
    Country
    CN
    Correspondent
    Zhang GENESCIENCE

    US Agent

    Business Name
    Precision Diagnostics INC
    Contact Name
    Jianwei Zheng
    Address
    16321 MAIN ST 130-366, Chino
    City
    Chino
    State
    CA
    ZIP
    91708
    Country
    US
    Email
    [email protected]
    Phone
    508 3489888

    Products

    Device Name Product Code
    Tourniquet, Nonpneumatic GAX
    Products, Red-Cell Lysing Products GGK
    Reagent, Coronavirus Serological QKO
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Bath, Flotation, Tissue IDY
    Dispensers, Paraffin IDW
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Container, Specimen, Sterile FMH
    Calculator/Data Processing Module, For Clinical Use JQP
    Clinical Sample Concentrator JJH
    Slide Stainer, Automated KPA
    Carbol Fuchsin ICL
    Airway, Nasopharyngeal BTQ
    Container, Specimen, Non-Sterile NNI
    Stain, Papanicolau HZJ
    Tourniquet, Pneumatic KCY
    Micro Pipette JRC
    Stethoscope, Manual LDE
    Device, Accessory, Cooling Plate For Tissue Embedding Station MXT
    Microtome, Rotary IDO
    Culture Media, Non-Selective And Non-Differential JSG
    Immunohistochemistry Reagents And Kits NJT
    Cytocentrifuge IFB
    Block, Heating JRG
    Hematoxylin HYJ
    General Purpose Reagent PPM
    Agent, Clearing KEM
    Coverslips, Microscope Slide KES
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Applicator, Absorbent Tipped, Sterile KXG

    Proprietary Names

    Tourniquet, Nonpneumatic Red Blood Cell Lysis Buffer Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography) Sample Preservation Solution Disposable breathing circuit Tissue Floating Bath TF-45 Tissue Floating Bath&Slide Dryer WBFT-60 Paraffin Dispensers (EMB-03) Paraffin Dispensers (EMB-01) Paraffin Dispensers (EMB-02) Automatic Sorting&Checking Machine S1600/S1600V Chaser SPS slides laser Printer GSSPS-S Automatic Sorting&Checking Machine S800V Specimen High-Speed Pneumatic Transport System Whistle-O Pasteur Pipette Automatic Sorting&Checking Machine S1800V Specimen High-Speed Pneumatic Transport System Whistle-M Chaser CPS Embedding Cassette laser printer: GSCPS280,GSCPS-6,GSCPS-1,GSCPS-S,GSCPS-4,GSCPS-E Transport Tube Specimen Container Saliva Collection Kit Urine Collection Kit Urine Cup Sample Dispensing System Magic-8000Plus Nucleic Acid (DNA) Extraction Kit Nucleic Acid (RNA) Extraction Kit Nucleic Acid Extraction Kit SMART-05 Nucleic Acid Extractor Full-Auto IHC Stainer (P17) Full-Auto Slide Stainer & Coverslipper (GSM230) Fully Automated Special Staining System Automated Liquid-Based Cytology Slide Preparation Machine GSTCT-50 Full-Auto IHC Stainer (P17 plus) Liquid-based Thin Layer Cytology Slide System GSTCT-40plus Full-Auto Slide Stainer & Coverslipper Automatic Frozen Section Staining and Coverslipping Machine (GSM210-1/GSM210-2) Liquid-based Thin Layer Cytology Slide System GSTCT-18 Acid-fast Bacillus Staining Kit nasopharyngeal airway Saliva Collector Papanicolaou Stain Tourniquet, Pneumatic Micro Pipettes Pipette Tips STETHOSCOPE Clod Plate EML-01 Microtome Disposable Virus Sampling Swab Kit Vaginal Swab Kit Cervical Swab Kit Anti-CD3 Monoclonal Primary Antibody Anti-Cytokeratin Monoclonal Primary Antibody Anti-S100 Monoclonal Primary Antibody Anti-CD20 Monoclonal Primary Antibody Anti-Desmin Monoclonal Primary Antibody Anti-Estrogen Receptor (ER) Monoclonal Primary Antibody Anti-HER2/neu Monoclonal Primary Antibody Anti-CD68 Monoclonal Primary Antibody Anti-PSA Monoclonal Primary Antibody Anti-CD34 Monoclonal Primary Antibody Anti-P53 Monoclonal Primary Antibody Anti-Ki67 Monoclonal Primary Antibody Anti-Smooth Muscle Actin (SMA) Monoclonal Primary Antibody Anti-Vimentin Monoclonal Primary Antibody Anti-Progesterone Receptor (PR) Monoclonal Primary Antibody Cell Block Preparation Kit Smart Cell Block System (BK-TYPE01) Smart Cell Block System Hot Plate TB-45 Hematoxylin-Eosin Staining Solution Blocking Reagent Secondary Antibodies Kit Citrate Antigen Retrieval Solution High pH Antigen Retrieval Solution Dewaxing Solution PAP (Peroxidase-Antiperoxidase) Reagent Wash Buffer DAB (Diaminobenzidine) Reagent Greener Dewaxing Agent Pathology Slide Kit Stool Collection Kit Antiseptic Swab Sticks/Applicators Nasopharyngeal/Oropharyngeal Specimen collection swab Cervical Specimen Collection Flocked Swab Cervical Specimen Collection Swab Vaginal Swab

    Establishment Types

    Manufacture Medical Device