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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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No Description
DIASORIN MOLECULAR LLC
MOL1001
In Commercial Distribution

  • 10816101025005 ()
MOL1001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 96 Molecular System
Neumodx Molecular, Inc.
500200
In Commercial Distribution

  • 00814278020000 ()
  • 10814278020724 ()

  • Width: 137.2 Centimeter
  • Height: 109.2 Centimeter
  • Depth: 109.2 Centimeter
500200

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 288 Molecular System
Neumodx Molecular, Inc.
500100
In Commercial Distribution

  • 00814278020727 ()
  • 10814278020014 ()

  • Depth: 109.2 Centimeter
  • Width: 182.9 Centimeter
  • Height: 190.5 Centimeter
500100

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Alinity m System
ABBOTT MOLECULAR INC.
08N53-002
In Commercial Distribution

  • 00884999048034 ()
08N53-002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
m2000rt Instrument System
ABBOTT MOLECULAR INC.
9K15-01
In Commercial Distribution

  • 00884999031814 ()
9K15-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07402759190
In Commercial Distribution

  • 00875197005660 ()
07402759190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
BIOFIRE DEFENSE, LLC
COMP-SUB-0034
In Commercial Distribution

  • 00851458005297 ()
COMP-SUB-0034

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005129 ()
NGDS-ASY-0002U

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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