BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    AllergiEnd ST-9

    DI: B6821001360 · Model: 1001-36 · MEDSCIENCE RESEARCH GROUP, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AllergiEnd ST-9
    Primary DI
    B6821001360
    Version / Model
    1001-36
    Catalog Number
    1001-36
    Company Name
    MEDSCIENCE RESEARCH GROUP, INC.
    Labeler DUNS
    013114656
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-30
    Public Version
    3
    Public Version Date
    2021-08-30
    Public Version Status
    Update
    Public Device Record Key
    2923802c-d67d-409d-90f5-4a40396ddca0
    Distribution End Date
    2021-08-30

    Device Description

    36 Well Test Tray

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LDH System, Delivery, Allergen And Vaccine

    GMDN Terms

    Code Name
    61298 General laboratory assay tray

    Identifiers

    Type ID
    Primary B6821001360

    Customer Contacts

    Phone
    5614990411
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K172062 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 140 Degrees Fahrenheit