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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
MERIDIAN BIOSCIENCE, INC.
610210
In Commercial Distribution

  • 00840733102318 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Universal IPPB Circuit
TELEFLEX INCORPORATED
IPN913682
In Commercial Distribution

  • 24026704645767 ()
  • 14026704645760 ()
1560

  • Ventilator breathing circuit, single-use
BD Viper™ SDA Extraction Reagent Trough
BECTON, DICKINSON AND COMPANY
441994
In Commercial Distribution

  • 30382904419944 ()
  • 00382904419943 ()
441994

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper Neutralization Pouch
BECTON, DICKINSON AND COMPANY
441354
In Commercial Distribution

  • 30382904413546 ()
  • 00382904413545 ()
441354

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Accessory kit
BECTON, DICKINSON AND COMPANY
442967
In Commercial Distribution

  • 00382904429676 ()
442967

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System SDA Accessory Kit
BECTON, DICKINSON AND COMPANY
442958
In Commercial Distribution

  • 00382904429584 ()
442958

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Tube/Tray Kit
BECTON, DICKINSON AND COMPANY
442957
In Commercial Distribution

  • 00382904429577 ()
442957

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ Extraction Reagent and Lysis Trough
BECTON, DICKINSON AND COMPANY
441128
In Commercial Distribution

  • 00382904411282 ()
441128

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Torch Module)
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0003-W
In Commercial Distribution

  • 00815381029089 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Torch System Base)
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0001-W
In Commercial Distribution

  • 00815381029072 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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