BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N LP(a) Standard SY

    DI: 00630414285009 · Model: 10873686 · Siemens Healthcare Diagnostics Products GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    N LP(a) Standard SY
    Primary DI
    00630414285009
    Version / Model
    10873686
    Catalog Number
    OQCV07
    Company Name
    Siemens Healthcare Diagnostics Products GmbH
    Labeler DUNS
    388240673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2020-10-12
    Public Version
    2
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    401ecc3f-fcc9-4ec2-932a-2e4f8a36ef17

    Device Description

    Calibration of Lp(a) assay on BN Systems

    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
    JIS Calibrator, primary

    GMDN Terms

    Code Name
    41417 Lipoprotein A IVD, calibrator

    Identifiers

    Type ID
    Unit of Use 00630414287430
    Primary 00630414285009

    Customer Contacts

    Phone
    +1(800)664-3822
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K013126 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius