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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 Type Device Class Implantable

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CellaVision® Body Fluid Application DM1200 - 07350040972557

The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-120099
In Commercial Distribution

  • 07350040972557 ()
CBF-120099

  • Laboratory instrument/analyser application software IVD

Acuitas - 20812125010086

Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution

  • 20812125010086 ()
CP3511

  • Laboratory instrument/analyser application software 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 - 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

SecurView DX Manager - 15420045507388

The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations.
Hologic, Inc.
SVDX Manager
In Commercial Distribution

  • 15420045507388 ()
SVDX-00600-HIRES

  • Laboratory instrument/analyser application software IVD

SecurViewRT Manager - 15420045507371

The SecurView® RT technologist workstation Manager provides central database access and performs the image preparation for all connected SecurView RT Client workstations.
Hologic, Inc.
SVRT Manager
In Commercial Distribution

  • 15420045507371 ()
SVRT-00600R

  • Laboratory instrument/analyser application software IVD

SecurViewRT Mammorgraphy Workstation - 15420045507364

The SecurView® RT technologist workstation is intended to be used by technologists to view images durign screening and diagnostic exams.
Hologic, Inc.
SVRT
In Commercial Distribution

  • 15420045507364 ()
SVRT-00300

  • Laboratory instrument/analyser application software IVD

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD
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