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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Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500990 ()
CMP-00815

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500983 ()
71278-001

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500976 ()
71964-001

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500945 ()
71074-001

  • Laboratory instrument/analyser application software IVD
A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500938 ()
71050-001

  • Laboratory instrument/analyser application software IVD
A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500921 ()
70564-001

  • Laboratory instrument/analyser application software IVD
A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500914 ()
ASY-06042

  • Laboratory instrument/analyser application software IVD
A microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045500891 ()
71062-001

  • Basic light microscope
Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.
Hologic, Inc.
ThinPrep 3000 Processor
Not in Commercial Distribution

  • 15420045500846 ()
70150-001

  • Microscope slide maker IVD
Accessory kit with components for installation of the ThinPrep® 5000 processor with autoloader.
Hologic, Inc.
TP-5000 Autoloader Accessory Kit
In Commercial Distribution

  • 15420045513952 ()
ASY-08988

  • Microscope slide maker IVD
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