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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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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
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
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
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
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
Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN PRO TRACKER V 7.X
In Commercial Distribution

  • 09120052070910 ()


  • Laboratory instrument/analyser application software IVD
Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN PRO V 7.X
In Commercial Distribution

  • 09120052070880 ()


  • Laboratory instrument/analyser application software IVD
ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00
ABBOTT LABORATORIES
8K51-07
In Commercial Distribution

  • 00380740161323 ()
08K5107

  • Laboratory instrument/analyser application software IVD
ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00
ABBOTT LABORATORIES
8K50-07
In Commercial Distribution

  • 00380740161316 ()
08K5007

  • Laboratory instrument/analyser application software IVD
Alinity i B_hCG Assay File
Abbott GmbH
07P515A
In Commercial Distribution

  • 00380740160807 ()
07P515A

  • Laboratory instrument/analyser application software IVD
Alinity c Iron Assay File
Abbott GmbH
08P391B
In Commercial Distribution

  • 00380740160791 ()
08P391B

  • Laboratory instrument/analyser application software IVD
Alinity c MagnesiumU Assay File
Abbott GmbH
08P193B
In Commercial Distribution

  • 00380740160784 ()
08P193B

  • Laboratory instrument/analyser application software IVD
Alinity c Magnesium Assay File
Abbott GmbH
08P191B
In Commercial Distribution

  • 00380740160777 ()
08P191B

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-23
Not in Commercial Distribution

  • 00380740159429 ()
04P5723

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-20
Not in Commercial Distribution

  • 00380740159412 ()
04P5520

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R89-21
In Commercial Distribution

  • 00380740158255 ()
03R8921

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000sr System e-Assay CD ROM
ABBOTT LABORATORIES
4P57-22
Not in Commercial Distribution

  • 00380740157067 ()
04P5722

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-19
Not in Commercial Distribution

  • 00380740157050 ()
04P5519

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P06-3A
In Commercial Distribution

  • 00380740156909 ()
05P063A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P06-1A
In Commercial Distribution

  • 00380740156893 ()
05P061A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P08-3A
In Commercial Distribution

  • 00380740156886 ()
05P083A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P08-1A
In Commercial Distribution

  • 00380740156879 ()
05P081A

  • Laboratory instrument/analyser application software IVD
Alinity c SerBENZSQ Assay File
Abbott GmbH
09P531A
In Commercial Distribution

  • 00380740155865 ()
09P531A

  • Laboratory instrument/analyser application software IVD
Alinity i tHCY-DIL Assay File
Abbott GmbH
09P283A
In Commercial Distribution

  • 00380740155797 ()
09P283A

  • Laboratory instrument/analyser application software IVD
Alinity i AFP Assay File
Abbott GmbH
07P901B
In Commercial Distribution

  • 00380740154455 ()
07P901B

  • Laboratory instrument/analyser application software IVD
Alinity i HAV-IgM US Assay File
Abbott GmbH
08P281A
In Commercial Distribution

  • 00380740154448 ()
08P281A

  • Laboratory instrument/analyser application software IVD
Alinity i HAV-IgG US Assay File
Abbott GmbH
08P271A
In Commercial Distribution

  • 00380740154431 ()
08P271A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu %N Assay File
Abbott GmbH
08P117A
In Commercial Distribution

  • 00380740154424 ()
08P117A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu C2 Assay File
Abbott GmbH
08P118A
In Commercial Distribution

  • 00380740154417 ()
08P118A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu C1 Assay File
Abbott GmbH
08P119A
In Commercial Distribution

  • 00380740154400 ()
08P119A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu Assay File
Abbott GmbH
08P103A
In Commercial Distribution

  • 00380740154394 ()
08P103A

  • Laboratory instrument/analyser application software IVD
Alinity i HIVAg/AbUS Assay File
Abbott GmbH
08P073A
In Commercial Distribution

  • 00380740154387 ()
08P073A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HCVUS Assay File
Abbott GmbH
08P051A
In Commercial Distribution

  • 00380740154370 ()
08P051A

  • Laboratory instrument/analyser application software IVD
Alinity i AntiHBc M Assay File
Abbott GmbH
07P863A
In Commercial Distribution

  • 00380740154363 ()
07P863A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HBcUS Assay File
Abbott GmbH
07P841A
In Commercial Distribution

  • 00380740154356 ()
07P841A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR e-Assay CD-ROM
ABBOTT LABORATORIES
04P5721
Not in Commercial Distribution

  • 00380740153441 ()
04P5721

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
04P5518
Not in Commercial Distribution

  • 00380740153434 ()
04P5518

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD
Alinity c Valproic Assay File
Abbott GmbH
09P921A
In Commercial Distribution

  • 00380740152123 ()
09P921A

  • Laboratory instrument/analyser application software IVD
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