BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ROM Plus Fetal Membranes Rupture Test

    Reg #: 1722684 · FEI: 1000220650 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CLINICAL INNOVATIONS, LLC
    Registration Number
    1722684
    FEI Number
    1000220650
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    747 W 4170 S
    City
    MURRAY
    State
    UT
    ZIP
    84123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110605

    Owner / Operator

    Firm Name
    Clinical Innovations, LLC
    Operator Number
    10035300
    Address
    747 W 4170 S
    City
    Murray
    State
    UT
    Postal Code
    84123
    Country
    US
    Correspondent
    Nicole Boser

    Products

    Device Name Product Code
    Immunoassay For Detection Of Amniotic Fluid Protein(S). NQM
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    ROM Plus Fetal Membranes Rupture Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device