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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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GeneXpert® - 07332940007720

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
CEPHEID
GX-INFINITY 80
In Commercial Distribution

  • 07332940007720 ()
GX-INFINITY 80

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert® - 07332940007713

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
CEPHEID
GX-INFINITY 48S
In Commercial Distribution

  • 07332940007713 ()
GX-INFINITY 48S

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert® - 07332940007706

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-XVI R2
In Commercial Distribution

  • 07332940007706 ()
GX-XVI R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert® - 07332940007690

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-IV R2
In Commercial Distribution

  • 07332940007690 ()
GX-IV R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert® - 07332940007683

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-II R2
In Commercial Distribution

  • 07332940007683 ()
GX-II R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert® - 07332940007195

Xpress System
CEPHEID
GXIV-HUB
In Commercial Distribution

  • 07332940007195 ()
900-0828

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-80 System - 07332940006860

XPERT, GENEXPERT DX SYSTEM
CEPHEID
INFINITY 48-48
In Commercial Distribution

  • 07332940006860 ()
900-0457

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-80 System - 07332940006853

Additional catalog number: 900-0456R
CEPHEID
INFINITY 48-40
In Commercial Distribution

  • 07332940006853 ()
900-0456

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-80 System - 07332940006846

Additional catalog number: 900-0455R
CEPHEID
INFINITY 48-32
In Commercial Distribution

  • 07332940006846 ()
900-0455

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-80 System - 07332940006839

Additional catalog number: 900-0454R
CEPHEID
INFINITY 48-24
In Commercial Distribution

  • 07332940006839 ()
900-0454

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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