BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    YD DIAGNOSTICS

    Reg #: 9710094 · FEI: 3003347234 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    YD DIAGNOSTICS
    Registration Number
    9710094
    FEI Number
    3003347234
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    76, Seori-ro, Idong-eup, Cheoin-gu
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K060953

    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 St
    City
    S Pasadena
    State
    CA
    ZIP
    91030
    Country
    US
    Email
    [email protected]
    Phone
    626 4036565

    Products

    Device Name Product Code
    Preservative, Cytological LEA
    Reagent, Occult Blood KHE
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Automated Urinalysis System KQO
    Test, Urine Leukocyte LJX
    Slides, Microscope KEW
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Enzymatic Method, Creatinine JFY
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Refractometer For Clinical Use JRE
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Blood, Occult, Colorimetric, In Urine JIO
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Fixative, Alcohol Containing LDZ

    Proprietary Names

    EASYPREP Preservative Solution Occultech FOB Test Uriscan S-300 EASYPREP SLIDE GLASS Uriscan Optima + Uriscan 2ACR Strip Uriscan Optima + Uriscan Multiple parameter strips Uriscan Urine Test Strips PREG-Q Pregnancy Test EASYPREP FIXATIVE SOLUTION Uriscan PROII Uriscan Optima + Uriscan 10ACR Strip

    Establishment Types

    Manufacture Medical Device