BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RAMP® RSV Control Swabs

    DI: 10627966005206 · Model: C1136 · Response Biomedical Corp
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    RAMP® RSV Control Swabs
    Primary DI
    10627966005206
    Version / Model
    C1136
    Catalog Number
    C1136
    Company Name
    Response Biomedical Corp
    Labeler DUNS
    248609018
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-31
    Public Version
    3
    Public Version Date
    2025-11-14
    Public Version Status
    Update
    Public Device Record Key
    9eac1daf-38d1-48cf-a829-b3f5de8f0512

    Device Description

    The RAMP® RSV control swabs are additional external control reagents to be used with RAMP® RSV test kits as part of a routine quality control program

    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
    GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

    GMDN Terms

    Code Name
    52808 Respiratory syncytial virus (RSV) antigen IVD, control

    Identifiers

    Type ID
    Primary 10627966005206

    Customer Contacts

    Phone
    +1.888.525.7267
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K091235 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 5 positive control and 5 negative control swabs

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store at 2 to 30 degrees Celsius. Do not freeze. Contents are stable until the expiration date printed on the box.