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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys Anti-HCV II

    DI: 07613336154311 · Model: 06427405160 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys Anti-HCV II
    Primary DI
    07613336154311
    Version / Model
    06427405160
    Catalog Number
    06427405160
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-03
    Public Version
    4
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    3ea84d2c-d26d-4a8b-a225-c6928a2e0dc3

    Device Description

    Anti-HCV II 200-Test Kit

    Device Characteristics

    Single Use
    Yes
    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
    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
    MZO Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus

    GMDN Terms

    Code Name
    48352 Hepatitis C virus antigen IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Previous 04015630936670
    Primary 07613336154311

    Premarket Submissions

    Submission Number Supplement Number
    P140021 008

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius