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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Leica Biosystems CytoVision Flexible Karyotyper License Activation
Leica Biosystems Richmond, Inc.
23SWR000FKX001
Not in Commercial Distribution

  • 00849832003625 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
CytoVision V7.6 configuration
Leica Biosystems Richmond, Inc.
23SWR00076CV
Not in Commercial Distribution

  • 00849832013419 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems Ariol TMA Module
Leica Biosystems Richmond, Inc.
23ASWTMA
In Commercial Distribution

  • 00849832007845 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems Ariol Batch Processing Module
Leica Biosystems Richmond, Inc.
23ASWBATCH
In Commercial Distribution

  • 00849832007821 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems Ariol Slide Exporter (SCN for DIH)
Leica Biosystems Richmond, Inc.
23ASASE
In Commercial Distribution

  • 00849832007814 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision CytoLink Development System
Leica Biosystems Richmond, Inc.
23REV009KFXCL1
Not in Commercial Distribution

  • 00849832005001 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision CytoLink Data Service Module
Leica Biosystems Richmond, Inc.
23SVRCYTOLINK
Not in Commercial Distribution

  • 00849832004998 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station upgrade use existing Jai M4
Leica Biosystems Richmond, Inc.
23CUP003CVX720
Not in Commercial Distribution

  • 00849832004578 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Capture station upgrade use existing DFC
Leica Biosystems Richmond, Inc.
23CUP004CVX710
Not in Commercial Distribution

  • 00849832004516 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station Upgrade use existing Jai CVM2
Leica Biosystems Richmond, Inc.
23CUP005CVMV2
Not in Commercial Distribution

  • 00849832004493 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
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