BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Atellica™ IM Fol DTT/Releasing Agent

    DI: 00630414599007 · Model: 10995576 · 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 Fol DTT/Releasing Agent
    Primary DI
    00630414599007
    Version / Model
    10995576
    Catalog Number
    10995576
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-05
    Public Version
    6
    Public Version Date
    2024-06-07
    Public Version Status
    Update
    Public Device Record Key
    60386af4-2e4e-4a29-a894-5b039f6fe14c

    Device Description

    Folic Acid DTT/REL AGT - Atellica IM - 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
    CGN ACID, FOLIC, RADIOIMMUNOASSAY

    GMDN Terms

    Code Name
    43518 Dithiothriotol (DTT) reagent IVD

    Identifiers

    Type ID
    Primary 00630414599007

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K172201 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store Upright, Do not freeze, Resuspend.