BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dxpress Reader

    DI: 10743816001362 · Model: LSR-2000 · PRINCETON BIOMEDITECH CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dxpress Reader
    Primary DI
    10743816001362
    Version / Model
    LSR-2000
    Catalog Number
    LSR-2000-00
    Company Name
    PRINCETON BIOMEDITECH CORPORATION
    Labeler DUNS
    362917692
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    318e6b79-8168-4167-9bfd-48c30ea881ea

    Device Description

    Dxpress Reader/1 Unit

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

    GMDN Terms

    Code Name
    57864 Microplate reader IVD, semi-automated

    Identifiers

    Type ID
    Primary 10743816001362

    Customer Contacts

    Phone
    8005262125
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K050955 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 35 Degrees Celsius