BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Urea Nitrogen (BUN) Reagent

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

    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
    K981106

    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
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ

    Proprietary Names

    Urea Nitrogen (BUN) Reagent

    Establishment Types

    Repack or Relabel Medical Device