BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affymetrix

    DI: 00856826006159 · Model: 902108 · AFFYMETRIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affymetrix
    Primary DI
    00856826006159
    Version / Model
    902108
    Catalog Number
    902108
    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
    929f075e-7482-403f-b799-728f21c37590

    Device Description

    CytoScan® Dx Pre-PCR 2°-8°C MOD T E W

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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 00856826006159