BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Uriscan Urine Test Strips

    Reg #: 9710094 · FEI: 3003347234 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    YD DIAGNOSTICS
    Registration Number
    9710094
    FEI Number
    3003347234
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    76, Seori-ro, Idong-eup, Cheoin-gu
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K952307

    Owner / Operator

    Firm Name
    YD DIAGNOSTICS
    Operator Number
    9044716
    Address
    76, Seori-ro, Idong-myeon, Cheoin-gu
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    17127
    Country
    KR

    US Agent

    Business Name
    Biosys Laboratories, Inc.
    Contact Name
    Jerri Pih (Hoi) Jerri Hoi
    Address
    526 Mission Street South Pasadena
    City
    S Pasadena
    State
    CA
    ZIP
    91030
    Country
    US
    Email
    [email protected]
    Phone
    626 4036565

    Products

    Device Name Product Code
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Blood, Occult, Colorimetric, In Urine JIO
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Test, Urine Leukocyte LJX
    Refractometer For Clinical Use JRE

    Proprietary Names

    Uriscan Urine Test Strips

    Establishment Types

    Manufacture Medical Device