BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Applied Biosystems

    DI: 00856826006210 · Model: 2.1 · Affymetrix, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Applied Biosystems
    Primary DI
    00856826006210
    Version / Model
    2.1
    Catalog Number
    610525
    Company Name
    Affymetrix, Inc.
    Labeler DUNS
    804682573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-30
    Public Version
    2
    Public Version Date
    2025-02-12
    Public Version Status
    Update
    Public Device Record Key
    f14f1174-952e-4d3e-a19e-eb64d9608727

    Device Description

    Chromosome Analysis Suite Dx Software

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

    GMDN Terms

    Code Name
    61777 Human genomic analysis interpretive software

    Identifiers

    Type ID
    Primary 00856826006210