BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN YHLO BIOTECH CO., LTD.

    Reg #: 3017019647 · FEI: 3017019647 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    19

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    Registration Details

    Registration Name
    SHENZHEN YHLO BIOTECH CO., LTD.
    Registration Number
    3017019647
    FEI Number
    3017019647
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223690

    Owner / Operator

    Firm Name
    SHENZHEN YHLO BIOTECH CO., LTD.
    Operator Number
    10082247
    Address
    Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518116
    Country
    CN
    Correspondent
    Dan Wang

    US Agent

    Business Name
    LSI International Inc
    Contact Name
    Joe Shia
    Address
    504E Diamond Ave., Suite H
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

    Device Name Product Code
    Radioimmunoassay, Immunoreactive Insulin CFP
    Cuvette, Thermostated JRI
    Radioimmunoassay, Total Thyroxine CDX
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Antisera, All Mycoplasma Spp. GSA
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Device, Automated Sedimentation Rate GKB
    System, Test, Human Chorionic Gonadotropin DHA
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Radioassay, Triiodothyronine Uptake KHQ
    Radioimmunoassay, Estradiol CHP
    General Purpose Reagent PPM
    Instrumentation For Clinical Multiplex Test Systems NSU
    Radioimmunoassay, Human Growth Hormone CFL
    Radioimmunoassay, Progesterone JLS
    Radioimmunoassay, Luteinizing Hormone CEP
    Radioimmunoassay, Total Triiodothyronine CDP

    Proprietary Names

    iFlash-Insulin Reaction Vessel iFlash-T4 iFlash-C-Peptide iFlash-DHEA-S iFlash-Mycoplasma pn. IgM iFlash-Mycoplasma pn. IgG iFlash-FSH VISION ESR Analyzer; VISION-A, VISION-B, VISION-C, VISION Pro-A, VISION Pro-B, VISION Pro-C Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) iFlash-HCG iFlash-Prolactin iFlash-FT3 iFlash-E2 iFlash-Cleaning Solution; Specification: 45mL*2 bottles, 30mL*2 bottles Trigger Solution (1X); Specification: 900mL*4 bottles, 500mL*4 bottles, 220mL*4 bottles Sample Diluent; Model: A, B, E, I, H, G, Specification: 45mL*2 bottles Pre-Trigger Solution (1X); Specification: 900mL*4 bottles, 500mL*4 bottles, 220mL*4 bottles Wash Buffer; Model: Wash Buffer (1X), Specification: 10L; Model: Wash Buffer (10X), Specification: 10L, 1L*4 bottles Sample Diluent; Model: I-1, Specification: 0.57mL*100 PCS Sample Diluent; Model: D, Specification: 120?L*100 PCS Immunofluorescence Reader I-UNICELL Incubator iFlash-hGH iFlash-Progesterone iFlash-LH iFlash-T3 iFlash 9000 CLIA Analyzer; iFlash 9000-A UNION Immune Analyzer; UNION-C Chemiluminescence Immunoassay Analyzer; iFlash 1800-A Chemiluminescence Immunoassay Analyzer; iFlash 3000-C Chemiluminescence Immunoassay Analyzer; iFlash 1200-A

    Establishment Types

    Manufacture Medical Device