BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pointe Carisporodol Metabolite (SOMA) Reagent Set

    DI: 00811727018397 · Model: 60-CM0740-1L · HORIBA INSTRUMENTS INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pointe Carisporodol Metabolite (SOMA) Reagent Set
    Primary DI
    00811727018397
    Version / Model
    60-CM0740-1L
    Catalog Number
    60-CM0740-1L
    Company Name
    HORIBA INSTRUMENTS INCORPORATED
    Labeler DUNS
    052845583
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-25
    Public Version
    2
    Public Version Date
    2025-10-02
    Public Version Status
    Update
    Public Device Record Key
    ddc618b6-8f80-4caf-be46-aa51d38de7ce

    Device Description

    Pointe Carisporodol Metabolite (SOMA) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Carisoprodol Metabolite (SOMA) Reagent Set is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    QBK Meprobamate Test System

    GMDN Terms

    Code Name
    63015 Carisoprodol IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00811727018397

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    DEN170010 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius