BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVIA Centaur HCV

    DI: 00630414278759 · Model: 11203483 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ADVIA Centaur HCV
    Primary DI
    00630414278759
    Version / Model
    11203483
    Catalog Number
    11203483
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-01
    Public Version
    4
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    4b5d45a7-0c37-4790-b776-d02e7264d068

    Device Description

    ADVIA Centaur HCV 200T Kit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    48366 Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

    Identifiers

    Type ID
    Primary 00630414278759

    Customer Contacts

    Phone
    +1(877)229-3711
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P030056 002
    P030056 003
    P030056 004
    P030056 005
    P030056 006
    P030056 007
    P030056 008
    P030056 009
    P030056 010
    P030056 011
    P030056 013

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store Upright, Protect from Light, Do Not Freeze, Resuspend