BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BD Onclarity HPV Assay

    Reg #: 1119779 · FEI: 1119779 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BECTON, DICKINSON & CO.
    Registration Number
    1119779
    FEI Number
    1119779
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7 LOVETON CIR.
    City
    SPARKS
    State
    MD
    ZIP
    21152
    Country
    US

    Regulatory Submissions

    PMA Number
    P160037

    Owner / Operator

    Firm Name
    Becton Dickinson and Company
    Operator Number
    9922032
    Address
    One Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Kit, Dna Detection, Human Papillomavirus MAQ

    Proprietary Names

    BD Onclarity HPV Assay Control set for the BD Onclarity HPV Assay BD FOX PCR Extraction Tubes BD Onclarity HPV Extraction Reagent Trough BD Onclarity HPV Assay LBC Diluent BD PCR Tube/Tray Kit, PCR Accessory Kit BD COR PX Instrument BD Onclarity HPV SurePath Diluent Tubes BD Viper LT System BD COR GX Instrument BD Onclarity HPV Self Collection Diluent Tube FLOQSwabs for HPV Self Collection

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device