BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Atellica™ IM HBeAg

    DI: 00630414599236 · Model: 10995600 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Atellica™ IM HBeAg
    Primary DI
    00630414599236
    Version / Model
    10995600
    Catalog Number
    10995600
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-16
    Public Version
    6
    Public Version Date
    2025-11-19
    Public Version Status
    Update
    Public Device Record Key
    1fbd285b-97da-4b1b-aa17-c08bc5065711

    Device Description

    Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T

    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
    LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm)

    GMDN Terms

    Code Name
    48331 Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414599236

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P090024 001
    P090024 002
    P090024 003
    P090024 004
    P090024 005

    Storage Conditions

    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.