BEUDAMED
    FDA Registration Active 🇨🇳 China

    XIAMEN ZEESAN BIOTECH CO., LTD

    Reg #: 3013540184 · FEI: 3013540184 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    85
    Establishment Types
    2
    Classifications
    6

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    Registration Details

    Registration Name
    XIAMEN ZEESAN BIOTECH CO., LTD
    Registration Number
    3013540184
    FEI Number
    3013540184
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 884-1 and 884-2 Lianting Road, (Xiang An) Industrial Area, Torch High-Tech Zone
    City
    Xiamen Fujian
    Country
    CN

    Owner / Operator

    Firm Name
    Xiamen Zeesan Biotech Co., Ltd
    Operator Number
    10060382
    Address
    No. 884-1 and 884-2 Lianting Road, (Xiang An) Industrial Area, Torch High-Tech Zone
    City
    Xiamen
    State
    Fujian
    Postal Code
    361101
    Country
    CN
    Correspondent
    Long Han

    US Agent

    Business Name
    Shenzhen Joyantech Consulting Co., Ltd.
    Contact Name
    Thomas Tang
    Address
    25 Hopewell Drive Stony Brook
    City
    Stony Brook
    State
    NY
    ZIP
    11790
    Country
    US
    Email
    [email protected]
    Phone
    631 7511103

    Products

    Device Name Product Code
    Instrumentation For Clinical Multiplex Test Systems NSU
    Research Use Only/Pathology OTU
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Applicator, Absorbent Tipped, Sterile KXG
    Clinical Sample Concentrator JJH
    Container, Specimen, Non-Sterile NNI

    Proprietary Names

    Real-Time PCR System, model: SLAN-96S, SLAN-96P, SLAN-48P ZEESAN, Sanity 2 System, model: Sanity2 ZEESAN, Respiratory Pathogen Panel (RPP 12D), 24 Tests/Kit, 48 Tests/Kit ZEESAN, CBF?-MYH11 Detection Kit, Model 20 Tests/Kit ZEESAN, Sanity-2 Respiratory Pathogen Panel (RPP4), Model 24 Tests/Kit ZEESAN, Sanity-2 MDR-TB Test Kit, Model 24 Tests/Kit ZEESAN, Sanity-2 Respiratory Pathogen Panel (RPP12), Model 24 Tests/Kit ZEESAN, RT Reagent Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.617 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, PML-RAR? S Detection Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Test Kit (Sanity 2), 24 Tests/Kit, 48 Tests/Kit ZEESAN, MeltPro® Low Risk HPV Genotyping Assay, 48 Tests/Kit ZEESAN, Sanity-2 Respiratory Pathogen Panel (RPP3), Model 24 Tests/Kit ZEESAN, SARS-CoV-2 Mutation Panel (Sanity 2), 24 Tests/Kit, 48 Tests/Kit ZEESAN, Leukemia Fusion Genes (Q55) Screening Probe Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.1.7 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, BCR-ABL1 Kinase Domain Mutation Screening Kit, Model 20 Tests/Kit ZEESAN, PML-RAR? Genotyping Kit, Model 20 Tests/Kit ZEESAN, MTB/RIF Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP4D), Model 48 Tests/Kit ZEESAN, High Risk HPV Genotyping Assay (MMCA), 48 Tests/Kit ZEESAN, Sanity-2 Monkeypox Virus Test Kit, Model 24 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.351 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, SARS-CoV-2 Mutation Panel, 24 Tests/Kit, 48 Tests/Kit ZEESAN, Sanity 2 Respiratory Pathogen Panel, 12 Tests/Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, PML-RAR? V Detection Kit, Model 20 Tests/Kit ZEESAN, PML RAR? L Detection Kit, Model 20 Tests/Kit ZEESAN, Sanity 2-MTB/MDR Test Kit, Model 24 Tests/Kit ZEESAN, MDR-TB Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP19D), Model 48 Tests/Kit ZEESAN, Mycobacteria Identification Kit (Sanity 2) , Model 24 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP17D), Model 48 Tests/Kit ZEESAN, Leukemia Fusion Genes (Q51) Screening Kit, Model 20 Tests/Kit ZEESAN, Mycobacteria Identification Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB/SL Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, STI-15 Detection Kit, Model 48 Tests/Kit ZEESAN, SARS-CoV-2 Variant P.1 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, Leukemia Fusion Genes (Q30) Screening Kit ZEESAN, BCR-ABL1 p190 Detection Kit, Model 20 Tests/Kit ZEESAN, Monkeypox Virus Test Kit, Model 48 Tests/Kit ZEESAN, MDR-TB Test Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, High Risk HPV Genotyping Kit (Sanity 2), 24 Tests/Kit ZEESAN, MTB Test Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, MTB/STR Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB Test Kit, Model 48 Tests/Kit ZEESAN, MTB/FQ Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB/MDR Test Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, Sanity-2 Mycobacteria Identification Kit, Model 24 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP3D) , Model 48 Tests/Kit ZEESAN, MTB/INH Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB/PZA Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, Sanity 2-MTB Test Kit, Model 24 Tests/Kit ZEESAN, WT1 Detection Kit , Model 20 Tests/Kit ZEESAN, AMLl-ETO Detection Kit, Model 20 Tests/Kit ZEESAN, BCR-ABL1 Genotyping Kit, Model 20 Tests/Kit ZEESAN, Leukemia Fusion Genes (Ph like) Screening Probe Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Test Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, BCR-ABL1 p210 Detection Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.617 Identification Kit (Sanity 2), 24 Tests/Kit, 48 Tests/Kit ZEESAN, MTB/EMB Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, SARS-CoV-2 Test Kit (Real-time PCR), 48 Test/Kit Disposable Sampling Swab, Type A-01, Type A-02, Type A-03, Type A-04, Type A-05 ZEESAN, Lab-Aid 960 Virus RNA Extraction Kit, 96 Tests/Kit ZEESAN, Nucleic Acid Extraction System, Lab-Aid 824s ZEESAN, Virus RNA Extraction Kit, 100 Tests/Kit ZEESAN, Nucleic Acid Extraction System, Lab-Aid 896 ZEESAN, Lab-Aid Virus RNA Extraction Kit, 48 Tests/Kit ZEESAN, Nucleic Acid Extraction System, Lab-Aid 960 ZEESAN, MTB DNA Extraction Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, Total RNA Blood Kit (Lab-Aid 896), 96 Tests/Kit ZEESAN, HPV DNA Extraction Kit (Sanity 2), 12 Tests/Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, DNA Extraction Kit (Lab-Aid 896), Model 96 Tests/Kit ZEESAN, Pathogen Nucleic Acid Extraction Kit (Lab-Aid 896), 96 Tests/Kit ZEESAN, Total RNA Blood Kit (Lab-Aid), 48 Tests/Kit ZEESAN, Lab-Aid 824s Blood DNA Extraction Kit, Model 48 Tests/Kit ZEESAN, HPV DNA Extraction Kit (Lab-Aid 896), 96 Tests/Kit ZEESAN, Sanity 2-Pathogen Nucleic Acid Extraction Kit, 24 Tests/Kit ZEESAN, Lab-Aid 824 HPV DNA Extraction Kit, 48 Tests/Kit ZEESAN, Lab-Aid 824s DNA Extraction Kit, Model 48 Tests/Kit ZEESAN, MTB DNA Extraction Kit (Lab-Aid 896), Model 96 Tests/Kit ZEESAN, Virus RNA Collection Kit, model V-2000 ZEESAN, Saliva RNA Sample Collection Kit, model R-2000 ZEESAN, Saliva RNA Sample Collection Kit, model R01-2000 ZEESAN, Virus RNA Collection Kit, model V01-1000, V01-2000, V01-3000 ZEESAN, Saliva Collection Kit, model SAL-2000L

    Establishment Types

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