BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affymetrix

    DI: 00856826006074 · Model: 1.2 · AFFYMETRIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affymetrix
    Primary DI
    00856826006074
    Version / Model
    1.2
    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
    2016-09-23
    Public Version
    4
    Public Version Date
    2021-11-23
    Public Version Status
    Update
    Public Device Record Key
    d653f4ac-a7e9-4f6a-a611-ad000dc9d53f

    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 00856826006074