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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Roche Molecular Systems, Inc.
03279332001
In Commercial Distribution

  • 04015630924745 ()
03279332001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay
ELITECHGROUP SPA
INT030-K
In Commercial Distribution

  • 03661540900006 ()
INT030-K

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus Deepwell Dx
BIO-RAD LABORATORIES, INC.
12016687
In Commercial Distribution

  • 03610522260829 ()

  • 1 ea
12016687

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 384 Dx
BIO-RAD LABORATORIES, INC.
12014335
In Commercial Distribution

  • 03610522203437 ()

  • 1 each
12014335

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 96 Dx
BIO-RAD LABORATORIES, INC.
12014330
In Commercial Distribution

  • 03610522203413 ()

  • 1 each
12014330

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1844095-IVD
In Commercial Distribution

  • 03610520550984 ()
1844095-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1845097-IVD
In Commercial Distribution

  • 03610520457818 ()
1845097-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
GENEXPERT Xpress System
CEPHEID
GX-IV Xpress
In Commercial Distribution

  • 07332940009243 ()
GX-IV Xpress

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-XVI R2
In Commercial Distribution

  • 07332940007706 ()
GX-XVI R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-IV R2
In Commercial Distribution

  • 07332940007690 ()
GX-IV R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-II R2
In Commercial Distribution

  • 07332940007683 ()
GX-II R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Xpress System
CEPHEID
GXIV-HUB
In Commercial Distribution

  • 07332940007195 ()
900-0828

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
INFINITY 48-48
In Commercial Distribution

  • 07332940006860 ()
900-0457

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0456R
CEPHEID
INFINITY 48-40
In Commercial Distribution

  • 07332940006853 ()
900-0456

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0455R
CEPHEID
INFINITY 48-32
In Commercial Distribution

  • 07332940006846 ()
900-0455

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0454R
CEPHEID
INFINITY 48-24
In Commercial Distribution

  • 07332940006839 ()
900-0454

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-1
In Commercial Distribution

  • 07332940006815 ()
900-0425

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-4
In Commercial Distribution

  • 07332940006761 ()
900-0398

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-8
In Commercial Distribution

  • 07332940006754 ()
900-0397

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-16
In Commercial Distribution

  • 07332940006747 ()
900-0395

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXXVI-12
In Commercial Distribution

  • 07332940006730 ()
900-0391

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-3
In Commercial Distribution

  • 07332940006723 ()
900-0144

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-1
In Commercial Distribution

  • 07332940006716 ()
900-0141

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-3
In Commercial Distribution

  • 07332940006709 ()
900-0139

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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
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
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
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
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
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
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
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
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
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
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
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
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