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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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GeneSTAT - A91004001

Automated PCR analyzer
DXNA LLC
91004001
In Commercial Distribution

  • A91004001 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BD PCR Cartridge - 30382904375196

BD PCR Cartridges 24EA
BECTON, DICKINSON AND COMPANY
437519
In Commercial Distribution

  • 30382904375196 ()
  • 00382904375195 ()
437519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Savanna - 30014613340089

Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382R
In Commercial Distribution

  • 30014613340089 ()
20382R

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Savanna - 30014613339304

Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382
In Commercial Distribution

  • 30014613339304 ()
20382

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Acuitas - 20812125010062

QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert® Xpress - 07332940009243

GENEXPERT Xpress System
CEPHEID
GX-IV Xpress
In Commercial Distribution

  • 07332940009243 ()
GX-IV Xpress

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

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

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
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