BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ISOLATOR™ 10 mL Microbial Tubes

    DI: 10811877010965 · Model: 50C7 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ISOLATOR™ 10 mL Microbial Tubes
    Primary DI
    10811877010965
    Version / Model
    50C7
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-05
    Public Version
    3
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    b36e2614-a7da-49d6-9ae4-bbdff851df17
    Distribution End Date
    2024-09-30

    Device Description

    The ISOLATOR™ 10 mL Microbial Tubes is intended for use in the collection and concentration of mircroorganisms from the blood.

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

    GMDN Terms

    Code Name
    61165 Blood cell lysis reagent IVD

    Identifiers

    Type ID
    Primary 10811877010965

    Premarket Submissions

    Submission Number Supplement Number
    K810664 000