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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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ThinPrep 3000 Processor - 15420045500846

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

ThinPrep 5000 Processor - 15420045513952

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

ThinPrep 5000 Processor - 15420045513945

Accessory kit with components for installation of the ThinPrep® 5000 processor.
Hologic, Inc.
TP-5000 Accessory Kit
In Commercial Distribution

  • 15420045513945 ()
71914-001

  • Microscope slide maker IVD

ThinPrep Imaging System - 15420045512535

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

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512511

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

  • 15420045512511 ()
CMP-01667

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045508163

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045508156

Server for use with the ThinPrep® Imaging System to enable review.
Hologic, Inc.
ThinPrep Imaging System Server
In Commercial Distribution

  • 15420045508156 ()
CMP-01535

  • Network server

ThinPrep Imaging System - 15420045508040

Automated cytology review microscope with ThinPrep® slide imaging functionality.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045508040 ()
ASY-07233

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507265

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

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507258

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

  • 15420045507258 ()
CMP-01515

  • Laboratory instrument/analyser application software IVD
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