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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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Leica Biosystems CytoVision Brightfield & FL ChromaScan upgrade - 00849832003779

Leca Biosystems CytoVision Brightfield & FL ChromaScan upgrade
Leica Biosystems Richmond, Inc.
23MBX008KFXUPG
Not in Commercial Distribution

  • 00849832003779 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version - 00849832003762

Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version
Leica Biosystems Richmond, Inc.
23GSLXXXKFXUPG
Not in Commercial Distribution

  • 00849832003762 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Karyotyping & FISH SW for Citrix - 00849832003731

Leica Biosystems CytoVision Karyotyping & FISH SW for Citrix
Leica Biosystems Richmond, Inc.
23SWR000KFX002
Not in Commercial Distribution

  • 00849832003731 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Remote User (Karyotype) - 00849832003717

Leica Biosystems CytoVision Remote User (Karyotype)
Leica Biosystems Richmond, Inc.
23SWRRMTKXX001
Not in Commercial Distribution

  • 00849832003717 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

BioPlex® 2200 - 00847865001281

U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 00847865001281 ()

  • 1 Each
665-3465A

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN PRO V7.4 - 09120052071092

This media contains V 7.4 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30185384 00
Not in Commercial Distribution

  • 09120052071108 ()
  • 09120052071092 ()
  • 09120052071115 ()
  • 09120052071122 ()
  • 09120052071139 ()
30185384

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN 7.3 SP2 - 09120052071023

This media contains the following registered Medical Devices: (DI) 09120052070996 MAGELLAN V7.X (DI) 09120052071009 MAGELLAN TRACKER V7.X
Tecan Austria GmbH
30182624 00
In Commercial Distribution

  • 09120052071023 ()
  • 09120052071030 ()
  • 09120052071047 ()
  • 09120052071054 ()
  • 09120052071061 ()
  • 09120052071078 ()
  • 09120052071085 ()
30182624

  • Laboratory instrument/analyser application software IVD

MAGELLAN - 09120052071009

Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN TRACKER V7.X
In Commercial Distribution

  • 09120052071009 ()
30183890

  • Laboratory instrument/analyser application software IVD

MAGELLAN - 09120052070996

Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN V7.X
In Commercial Distribution

  • 09120052070996 ()
30183889

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN PRO V 7.3 - 09120052070941

This media contains V 7.3 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30141795 00
Not in Commercial Distribution

  • 09120052070934 ()
  • 09120052070941 ()
  • 09120052070927 ()
  • 09120052070972 ()
  • 09120052070965 ()
30141795

  • Laboratory instrument/analyser application software IVD
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