ProbeChek UroVysion Bladder Cancer Kit Control Slides


Product Overview

ProbeChek UroVysion Bladder Cancer Kit Control Slides
UroVysion - 02J27-011


Device Description

A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired mutations associated with bladder cancer e.g., aneuploidies of chromosome 3, 7 and 17, in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Dessicated-protect from humidity
  • Storage Environment Temperature - Degrees Celsius
    • -20.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OYU

    Device Name: Dna-Probe Kit, Human Chromosome

    Device Class: 2

    Physical State: Reagents for identifying and enumerating human chromosomes

    Definition: Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.

    Submission Type ID: 1

    Review Panel: PA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: fluorescence in situ hybridization (FISH)

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: human cells

    Regulation Number: 866.4700

    Third Party Flag: N

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00884999002128

    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