BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Atellica™ IM HBcT

    DI: 00630414599205 · Model: 10995597 · 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 HBcT
    Primary DI
    00630414599205
    Version / Model
    10995597
    Catalog Number
    10995597
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-16
    Public Version
    6
    Public Version Date
    2026-02-09
    Public Version Status
    Update
    Public Device Record Key
    1effa7bf-ca1d-4a3a-96ab-d18afb3df570
    Distribution End Date
    2024-10-26

    Device Description

    HBC Total Ab (HBcT) - Atellica IM - RGT - 200T

    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
    SEI Qualitative and Quantitative Hepatitis B Virus Antibody assays

    GMDN Terms

    Code Name
    48304 Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00630414599205

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P040004 002
    P040004 003
    P040004 004
    P040004 005
    P040004 006
    P040004 007
    P040004 008
    P040004 009
    P040004 010
    P040004 011
    P040004 012
    P040004 013
    P040004 014

    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.