BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FilmArray® Respiratory Panel 2 plus (RP2plus)

    DI: 00815381020307 · Model: RFIT-ASY-0137 · BIOFIRE DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FilmArray® Respiratory Panel 2 plus (RP2plus)
    Primary DI
    00815381020307
    Version / Model
    RFIT-ASY-0137
    Catalog Number
    RFIT-ASY-0137
    Company Name
    BIOFIRE DIAGNOSTICS, LLC
    Labeler DUNS
    079280262
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-22
    Public Version
    6
    Public Version Date
    2022-07-28
    Public Version Status
    Update
    Public Device Record Key
    05d11f73-ac00-4478-8773-6259c7b76bb3
    Distribution End Date
    2022-06-27

    Device Description

    IVD reagent kit containing 6 tests

    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
    OOI Real Time Nucleic Acid Amplification System
    NSU Instrumentation For Clinical Multiplex Test Systems
    PZF Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

    GMDN Terms

    Code Name
    61527 Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00815381020307