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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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Instrument Max Clinical Refurb
BECTON, DICKINSON AND COMPANY
441927
In Commercial Distribution

  • 00382904419271 ()

  • Height: 72.4 Centimeter
  • Width: 94 Centimeter
  • Depth: 75.4 Centimeter
441927

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument Max Clinical
BECTON, DICKINSON AND COMPANY
441916
In Commercial Distribution

  • 00382904419165 ()

  • Height: 72.4 Centimeter
  • Width: 94 Centimeter
  • Depth: 75.4 Centimeter
441916

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD ProbeTec™ ET Instrument, Remanufactured
BECTON, DICKINSON AND COMPANY
440716
Not in Commercial Distribution

  • 00382904407162 ()

  • Depth: 28.5 Inch
  • Width: 28.5 Inch
  • Height: 21.5 Inch
440716

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680020 ()
QST-Dx1000-2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680013 ()
QST-Dx1000-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.
CHROMA ATE INC.
GenXplore q4800
In Commercial Distribution

  • 04719889100102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFEOS GENOMICS CORPORATION
md1000 Dx
In Commercial Distribution

  • 04719880531103 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Not in Commercial Distribution

62006

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument to process 2 Unyvero Cartridges
Curetis GmbH
A50 Analyzer
Not in Commercial Distribution

  • 04260364750003 ()
60001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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