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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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eSensor® Cystic Fibrosis Genotyping Test Detection Reagents (CF) (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005177 ()
MT002014

  • Cystic fibrosis IVD, kit, multiplex
eSensor® Cystic Fibrosis Genotyping Test Amplification Reagents (CF) (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005160 ()
MT002014

  • Cystic fibrosis IVD, kit, multiplex
eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex
eSensor® Cystic Fibrosis Genotyping Test Cartridge Pouch (CF) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005146 ()
KT020657

  • Cystic fibrosis IVD, kit, multiplex
No Description
FAXITRON BIOPTICS, LLC
PathVision 23x29
In Commercial Distribution

  • 00857069006289 ()


  • Stationary specimen x-ray system, digital
No Description
FAXITRON BIOPTICS, LLC
CoreVision 5x10
In Commercial Distribution

  • 00857069006272 ()


  • Stationary specimen x-ray system, digital
Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions.
FAXITRON BIOPTICS, LLC
VisionCT 15x15
In Commercial Distribution

  • 00857069006227 ()


  • Stationary specimen x-ray system, digital
Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
FAXITRON BIOPTICS, LLC
VersaVision 6x15
In Commercial Distribution

  • 00857069006203 ()


  • Stationary specimen x-ray system, digital
Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
FAXITRON BIOPTICS, LLC
VersaVision 12x15
In Commercial Distribution

  • 00857069006197 ()


  • Stationary specimen x-ray system, digital
Stationary digital specimen x-ray system with 10x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
FAXITRON BIOPTICS, LLC
VersaVision 10x15
In Commercial Distribution

  • 00857069006180 ()


  • Stationary specimen x-ray system, digital
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