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    FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·May 8, 2019

    FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·November 7, 2018

    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·May 13, 2026

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·May 13, 2026

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·June 4, 2025

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·April 16, 2025

    FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·September 18, 2024

    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 28, 2024

    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·September 18, 2024

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 14, 2024

    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·February 14, 2024

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·February 14, 2024

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·December 13, 2023

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·January 17, 2024

    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·January 17, 2024

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·November 21, 2018

    FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·March 18, 2020

    BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·March 10, 2021

    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·March 10, 2021

    BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·December 8, 2021