Vysis CEP X SpectrumOrange/ Y SpectrumGreen


Product Overview

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
Vysis - 07J22-050


Device Description

A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired aneuploidies associated with cancer, such as aneuploidies of chromosome 3, 7, and 17 (associated with bladder cancer) or chromosome 8 and 12 [associated with B-cell chronic lymphocytic leukaemia (CLL) and myeloid disorders such as chronic myeloid leukaemia (CML) and acute myeloid leukaemia (AML)], in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store unopened probe kit protected from light and humidity. Store 20X SSC salts and NP - 40 at room temperature. Store Slides in a sealed container with desiccant protected 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: KIR

    Device Name: Cells, Animal And Human, Cultured

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: PA

    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: 864.2280

    Third Party Flag: N

    Medical Specialty: HE


    Code: OXP

    Device Name: Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

    Device Class: 2

    Physical State: Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders

    Definition: X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.

    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: opposite-sex bone marrow transplantation for hematological disorders

    Regulation Number: 866.6010

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00884999027091

    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


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