BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affymetrix

    DI: 00856826006142 · Model: 902107 · Affymetrix, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Affymetrix
    Primary DI
    00856826006142
    Version / Model
    902107
    Catalog Number
    902107
    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
    6
    Public Version Date
    2025-02-12
    Public Version Status
    Update
    Public Device Record Key
    50e545fd-9902-43a9-8cde-dd51eb854116

    Device Description

    CytoScan™ Dx Pre-PCR -20°C MOD R L A

    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
    62428 Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00856826006142