BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BD Vaginal Panel on BD COR System

    DI: 00382904439767 · Model: 443976 · BECTON, DICKINSON AND COMPANY
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BD Vaginal Panel on BD COR System
    Primary DI
    00382904439767
    Version / Model
    443976
    Catalog Number
    443976
    Company Name
    BECTON, DICKINSON AND COMPANY
    Labeler DUNS
    122561087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-02
    Public Version
    2
    Public Version Date
    2025-05-09
    Public Version Status
    Update
    Public Device Record Key
    651471d4-9bad-4c1e-a2da-b74949a3a2df

    Device Description

    Kit Vaginal Reagent COR IVD

    Device Characteristics

    Single Use
    Yes
    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
    NSU Instrumentation for clinical multiplex test systems
    PQA Vaginitis and bacterial vaginosis nucleic acid detection system
    OUY Trichomonas vaginalis nucleic acid amplification test system
    OOI real time Nucleic acid amplification system

    GMDN Terms

    Code Name
    48208 Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00382904439767

    Customer Contacts

    Phone
    +1(800)638-8663
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K223653 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 27 Degrees Celsius