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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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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
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
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
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
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
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
Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.
Hologic, Inc.
ThinPrep 5000 Processor
In Commercial Distribution

  • 15420045504158 ()
71362-001

  • Microscope slide maker IVD
Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504103 ()
ASY-08346

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

  • 15420045504097 ()
ASY-06281

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

  • 15420045504080 ()
ASY-06284

  • Laboratory instrument/analyser application software IVD
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