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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® - 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

GeneXpert Dx System - 07332940006730

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-12
In Commercial Distribution

  • 07332940006730 ()
900-0391

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006723

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-3
In Commercial Distribution

  • 07332940006723 ()
900-0144

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006716

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

  • 07332940006716 ()
900-0141

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940006709

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-3
In Commercial Distribution

  • 07332940006709 ()
900-0139

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004910

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N17-1
In Commercial Distribution

  • 07332940004910 ()
SC2500N17-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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