3 results
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32ms
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Sources: EU EUDAMED, US FDA
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JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.
FDA Enforcement
Class III
·Terminated·Biofire Defense·September 24, 2014
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
FDA Enforcement
Class II
·Ongoing·Biofire Defense·October 1, 2025
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
FDA Enforcement
Class III
·Terminated·Biofire Defense·March 11, 2020