BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit

    DI: 00860009842236 · Model: K-INV-N-CARRIER / 000 · Invitae Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit
    Primary DI
    00860009842236
    Version / Model
    K-INV-N-CARRIER / 000
    Catalog Number
    K-INV-N-CARRIER / 000
    Company Name
    Invitae Corporation
    Labeler DUNS
    961750416
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    717017b4-be8b-4b79-ab7e-b48173e1c101

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    PQD Blood Specimen Collection Convenience Kit (Excludes Hiv)

    GMDN Terms

    Code Name
    62773 General specimen collection kit IVD, clinical

    Identifiers

    Type ID
    Primary 00860009842236