BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Urine Reagent Strip URS-10

    Reg #: 3005146313 · FEI: 3005146313 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    SANZAY CORPORATION -
    Registration Number
    3005146313
    FEI Number
    3005146313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1080 NW 163rd Drive
    City
    Miami Gardens
    State
    FL
    ZIP
    33169
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970250

    Owner / Operator

    Firm Name
    Sanzay Corporation - Integrated Diagnostics Group
    Operator Number
    10026301
    Address
    1080 NW 163RD DRIVE
    City
    Miami Gardens
    State
    FL
    Postal Code
    33169
    Country
    US
    Correspondent
    Maria R Sanchez

    Products

    Device Name Product Code
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Blood, Occult, Colorimetric, In Urine JIO
    Refractometer For Clinical Use JRE
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Electrolyte Controls (Assayed And Unassayed) JJR
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Test, Urine Leukocyte LJX

    Proprietary Names

    Urine Reagent Strip URS-10 Urine Reagent Strip URS-11

    Establishment Types

    Repack or Relabel Medical Device