BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    chemagic 360-D

    DI: 06438147356706 · Model: 2024-0010 · Wallac Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    chemagic 360-D
    Primary DI
    06438147356706
    Version / Model
    2024-0010
    Catalog Number
    2024-0010
    Company Name
    Wallac Oy
    Labeler DUNS
    540156544
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-25
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    f042b6f9-5593-4a16-927c-12ffa39f0fce

    Device Description

    The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJH Clinical Sample Concentrator

    GMDN Terms

    Code Name
    60528 Magnetic particle separation instrument IVD

    Identifiers

    Type ID
    Primary 06438147356706