BEUDAMED
    Product Code: OXP FDA class 2 21 CFR 866.6010

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

    Immunology

    The DNA-Probe Kit, Human Chromosome X and Y, BMT Engraftment is an in vitro diagnostic FISH probe kit intended to detect alpha satellite sequences on chromosome X and satellite III DNA on chromosome Y, used as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosomes X and Y in bone marrow specimens from recipients of opposite-sex bone marrow transplantation for hematological disorders. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OXP, with regulation number 866.6010 under the Immunology specialty, reviewed by the pathology panel.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

    Research product code OXP in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    OXP
    Device Class
    FDA class 2
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K954214 CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.