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    FDA UDI In Commercial Distribution 🇺🇸 United States

    RAMP® RSV TEST KIT; 25 TESTS

    DI: 10627966005183 · Model: C1108 · 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 TEST KIT; 25 TESTS
    Primary DI
    10627966005183
    Version / Model
    C1108
    Catalog Number
    C1108
    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
    4
    Public Version Date
    2025-11-14
    Public Version Status
    Update
    Public Device Record Key
    3e46882b-3cae-4147-a5a9-6950ca2fcc2a

    Device Description

    The RAMP® RSV test is a qualitative immunochromatographic test that utilizes the RAMP® 200 instrument for the detection of RSV F-protein antigens in nasal wash, nasopharyngeal aspirate (NP aspirate), and nasopharyngeal swab (NP swab) samples

    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
    62587 Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 10627966005183

    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 One test kit with 25 pouches, each containing 1 RAMP® test cartridge and 1 test tip, and 25 RAMP® buffer vials

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store unopened at 15 to 30°C (59 to 86°F). Do not freeze.