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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

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

SmartCycler Dx System - 07332940004903

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N18-1
In Commercial Distribution

  • 07332940004903 ()
SC2500N18-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004880

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N19-1
In Commercial Distribution

  • 07332940004880 ()
SC2500N19-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004866

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N2-1
In Commercial Distribution

  • 07332940004866 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004842

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N3-1
In Commercial Distribution

  • 07332940004842 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004835

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N3-1R
In Commercial Distribution

  • 07332940004835 ()
SC2500N3-1R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004804

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N4-1
In Commercial Distribution

  • 07332940004804 ()
SC2500N4-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004798

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N4-1R
In Commercial Distribution

  • 07332940004798 ()
SC2500N4-1R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004767

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N5-1
In Commercial Distribution

  • 07332940004767 ()
SC2500N5-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004743

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N6-1
In Commercial Distribution

  • 07332940004743 ()
SC2500N6-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004606

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N1-1
In Commercial Distribution

  • 07332940004606 ()
SC2500N1-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004583

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N12-1
In Commercial Distribution

  • 07332940004583 ()
SC2500N12-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004569

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N13-1
In Commercial Distribution

  • 07332940004569 ()
SC2500N13-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004545

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N14-1
In Commercial Distribution

  • 07332940004545 ()
SC2500N14-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004538

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N15-1
In Commercial Distribution

  • 07332940004538 ()
SC2500N15-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004521

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N16-1
In Commercial Distribution

  • 07332940004521 ()
SC2500N16-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Certified Pre-Owned GeneXpert Dx System - 07332940004408

No Description
CEPHEID
GXXVI-4-R
Not in Commercial Distribution

  • 07332940004408 ()
900-0518R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Certified Pre-Owned GeneXpert Dx System - 07332940004392

No Description
CEPHEID
GXXVI-8-R
Not in Commercial Distribution

  • 07332940004392 ()
900-0519R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Certified Pre-Owned GeneXpert Dx System - 07332940004385

No Description
CEPHEID
GXXVI-12-R
Not in Commercial Distribution

  • 07332940004385 ()
900-0520R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Certified Pre-Owned GeneXpert Dx System - 07332940004378

No Description
CEPHEID
GXXVI-16-R
Not in Commercial Distribution

  • 07332940004378 ()
900-0521R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940004361

XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-I
In Commercial Distribution

  • 07332940004361 ()
900-0523

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-48s System - 07332940004354

No Description
CEPHEID
INFINITY48-16
Not in Commercial Distribution

  • 07332940004354 ()
900-0536

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-48s System - 07332940004347

No Description
CEPHEID
INFINITY48-24
Not in Commercial Distribution

  • 07332940004347 ()
900-0537

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-48s System - 07332940004330

No Description
CEPHEID
INFINITY 48-32
Not in Commercial Distribution

  • 07332940004330 ()
900-0538

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-48s System - 07332940004323

No Description
CEPHEID
INFINITY 48-40
Not in Commercial Distribution

  • 07332940004323 ()
900-0539

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-48s System - 07332940004316

Additional catalog numbers: 900-0540L, 900-0540R
CEPHEID
INFINITY 48-48
Not in Commercial Distribution

  • 07332940004316 ()
900-0540

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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