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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® - 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

GeneXpert® - 07332940006822

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
CEPHEID
INFINITY48-16
In Commercial Distribution

  • 07332940006822 ()
900-0453

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006815

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-1
In Commercial Distribution

  • 07332940006815 ()
900-0425

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006761

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-4
In Commercial Distribution

  • 07332940006761 ()
900-0398

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006754

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-8
In Commercial Distribution

  • 07332940006754 ()
900-0397

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006747

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-16
In Commercial Distribution

  • 07332940006747 ()
900-0395

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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