This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.


Product Overview

This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.
UREA - UR9729


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Stable for at least 4 weeks at approximately +10°C.
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CDQ

    Device Name: Urease And Glutamic Dehydrogenase, Urea Nitrogen

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.1770

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 05055273206975

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos