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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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For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-96G
In Commercial Distribution

  • 06973843220277 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only.
Sansure Biotech Inc.
96-well, 0.2 mL block
In Commercial Distribution

  • 06955792700864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.
Biocartis NV
Idylla™ Console
In Commercial Distribution

  • 05415219000126 ()
P1010

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
Biocartis NV
Idylla™ Instrument
In Commercial Distribution

  • 05415219000119 ()
P0010

  • 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
Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001-W
In Commercial Distribution

  • 00815381029058 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Used IVD Instrument (SPOTFIRE® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002-W
In Commercial Distribution

  • 00815381020376 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (SPOTFIRE ® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002
In Commercial Distribution

  • 00815381020369 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Used IVD Instrument (SPOTFIRE® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001-W
In Commercial Distribution

  • 00815381020352 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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