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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Alinity c Opi1SQ Assay File
Abbott GmbH
09P655A
In Commercial Distribution

  • 00380740170417 ()
09P655A

  • Laboratory instrument/analyser application software IVD
Alinity c Opi2Q Assay File
Abbott GmbH
09P653A
In Commercial Distribution

  • 00380740170400 ()
09P653A

  • Laboratory instrument/analyser application software IVD
Alinity c Opi3Q Assay File
Abbott GmbH
09P651A
In Commercial Distribution

  • 00380740170394 ()
09P651A

  • Laboratory instrument/analyser application software IVD
Alinity c MethSQ Assay File
Abbott GmbH
09P643A
In Commercial Distribution

  • 00380740170387 ()
09P643A

  • Laboratory instrument/analyser application software IVD
Alinity c MethQ Assay File
Abbott GmbH
09P641A
In Commercial Distribution

  • 00380740170370 ()
09P641A

  • Laboratory instrument/analyser application software IVD
Alinity c EcstSQ Assay File
Abbott GmbH
09P583A
In Commercial Distribution

  • 00380740170363 ()
09P583A

  • Laboratory instrument/analyser application software IVD
Alinity c EcstQ Assay File
Abbott GmbH
09P581A
In Commercial Distribution

  • 00380740170356 ()
09P581A

  • Laboratory instrument/analyser application software IVD
Alinity c CocSQ1 Assay File
Abbott GmbH
09P557A
In Commercial Distribution

  • 00380740170349 ()
09P557A

  • Laboratory instrument/analyser application software IVD
Alinity c CocQ1 Assay File
Abbott GmbH
09P553A
In Commercial Distribution

  • 00380740170325 ()
09P553A

  • Laboratory instrument/analyser application software IVD
Alinity c CocQ Assay File
Abbott GmbH
09P551A
In Commercial Distribution

  • 00380740170318 ()
09P551A

  • Laboratory instrument/analyser application software IVD
Alinity c THC2SQ Assay File
Abbott GmbH
09P545A
In Commercial Distribution

  • 00380740170301 ()
09P545A

  • Laboratory instrument/analyser application software IVD
Alinity c THC1SQ Assay File
Abbott GmbH
09P543A
In Commercial Distribution

  • 00380740170295 ()
09P543A

  • Laboratory instrument/analyser application software IVD
Alinity c THC5Q Assay File
Abbott GmbH
09P541A
In Commercial Distribution

  • 00380740170288 ()
09P541A

  • Laboratory instrument/analyser application software IVD
Alinity c BenzSQ Assay File
Abbott GmbH
09P523A
In Commercial Distribution

  • 00380740170271 ()
09P523A

  • Laboratory instrument/analyser application software IVD
Alinity c BenzQ Assay File
Abbott GmbH
09P521A
In Commercial Distribution

  • 00380740170264 ()
09P521A

  • Laboratory instrument/analyser application software IVD
Alinity c BarbSQ Assay File
Abbott GmbH
09P513A
In Commercial Distribution

  • 00380740170257 ()
09P513A

  • Laboratory instrument/analyser application software IVD
Alinity c BarbQ Assay File
Abbott GmbH
09P511A
In Commercial Distribution

  • 00380740170240 ()
09P511A

  • Laboratory instrument/analyser application software IVD
Alinity c AmpSQ Assay File
Abbott GmbH
09P455A
In Commercial Distribution

  • 00380740170233 ()
09P455A

  • Laboratory instrument/analyser application software IVD
Alinity c Amp5Q Assay File
Abbott GmbH
09P453A
In Commercial Distribution

  • 00380740170226 ()
09P453A

  • Laboratory instrument/analyser application software IVD
Alinity c AmpQ Assay File
Abbott GmbH
09P451A
In Commercial Distribution

  • 00380740170219 ()
09P451A

  • Laboratory instrument/analyser application software IVD
Architect c8000 CRP1 eAssay CD-ROM
ABBOTT LABORATORIES
6K26-1A
In Commercial Distribution

  • 00380740169978 ()
06K261A

  • Laboratory instrument/analyser application software IVD
Architect cSystem e-Assay CD-ROM SI-Units/Alternate Units
ABBOTT LABORATORIES
4J62-19
In Commercial Distribution

  • 00380740169848 ()
04J6219

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem eAssay CD-ROM Conventional Units/Alternate Units
ABBOTT LABORATORIES
8G98-19
In Commercial Distribution

  • 00380740169831 ()
08G9819

  • Laboratory instrument/analyser application software IVD
ARCHITECT MULTIGENT e-ASSAY CD-ROM SI Units / Alternate Units
ABBOTT LABORATORIES
8K51-08
In Commercial Distribution

  • 00380740169046 ()
08K5108

  • Laboratory instrument/analyser application software IVD
ARCHITECT MULTIGENT e-ASSAY CD-ROM Conventional Units / Alternate Units
ABBOTT LABORATORIES
8K50-08
In Commercial Distribution

  • 00380740169039 ()
08K5008

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM - US
ABBOTT LABORATORIES
04P5724
In Commercial Distribution

  • 00380740166465 ()
04P5724

  • Laboratory instrument/analyser application software IVD
ARCHITECT iSystem e-Assay CD-ROM
ABBOTT LABORATORIES
04P5521
Not in Commercial Distribution

  • 00380740166458 ()
04P5521

  • Laboratory instrument/analyser application software IVD
Alinity c Lithium Assay File
Abbott GmbH
08P531B
In Commercial Distribution

  • 00380740166441 ()
08P531B

  • Laboratory instrument/analyser application software IVD
Alinity s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg Confirmatory e-Assay File
Abbott GmbH
06P035A
In Commercial Distribution

  • 00380740162931 ()
06P035A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg e-Assay File
Abbott GmbH
06P025A
In Commercial Distribution

  • 00380740162924 ()
06P025A

  • Laboratory instrument/analyser application software IVD
Alinity s Anti-HBc e-Assay File
Abbott GmbH
06P065A
In Commercial Distribution

  • 00380740162917 ()
06P065A

  • Laboratory instrument/analyser application software IVD
Alinity s Anti-HCV e-Assay File
Abbott GmbH
06P045A
In Commercial Distribution

  • 00380740162894 ()
06P045A

  • Laboratory instrument/analyser application software IVD
Alinity s HIV Ag/Ab Combo e-Assay File
Abbott GmbH
06P015A
In Commercial Distribution

  • 00380740162887 ()
06P015A

  • Laboratory instrument/analyser application software IVD
Alinity s Chagas e-Assay File
Abbott GmbH
06P085A
In Commercial Distribution

  • 00380740162863 ()
06P085A

  • Laboratory instrument/analyser application software IVD
Alinity i Myo STAT Assay File
Abbott GmbH
04V371A
In Commercial Distribution

  • 00380740162856 ()
04V371A

  • Laboratory instrument/analyser application software IVD
Alinity i CK-MB STAT Assay File
Abbott GmbH
04V381A
In Commercial Distribution

  • 00380740162849 ()
04V381A

  • Laboratory instrument/analyser application software IVD
Alinity c Bili Total Assay File
Abbott GmbH
04V511A
In Commercial Distribution

  • 00380740162832 ()
04V511A

  • Laboratory instrument/analyser application software IVD
Alinity c UIBC Assay File
Abbott GmbH
08P441B
In Commercial Distribution

  • 00380740161941 ()
08P441B

  • Laboratory instrument/analyser application software IVD
CellQuest Pro 4.0.2 Full Pack USB
BECTON, DICKINSON AND COMPANY
347527
Not in Commercial Distribution

  • 00382903475278 ()
347527

  • Laboratory instrument/analyser application software IVD
CellQuest Pro 4.0.2 Upgrade USB
BECTON, DICKINSON AND COMPANY
347526
Not in Commercial Distribution

  • 00382903475261 ()
347526

  • Laboratory instrument/analyser application software IVD
Retic-Count Upgrade Version 1.1
BECTON, DICKINSON AND COMPANY
343173
Not in Commercial Distribution

  • 00382903431731 ()
343173

  • Laboratory instrument/analyser application software IVD
Retic-Count S/W Version 1.1
BECTON, DICKINSON AND COMPANY
343130
Not in Commercial Distribution

  • 00382903431304 ()
343130

  • Laboratory instrument/analyser application software IVD
Procount Version 2.1 S/W
BECTON, DICKINSON AND COMPANY
341158
Not in Commercial Distribution

  • 00382903411580 ()
341158

  • Laboratory instrument/analyser application software IVD
Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound AS
Air R2 CL
In Commercial Distribution

  • 00195278640574 ()


  • Ultrasound imaging system application software
Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software
Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software
MD EchoPAC Plug-in v206
GE Vingmed Ultrasound AS
Plug-in v206
In Commercial Distribution

  • 00195278504326 ()


  • Ultrasound imaging system application software
Torrent Suite Dx SW, Installer V5.14.2
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A40001728
In Commercial Distribution

  • 10190302019958 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A40002323
In Commercial Distribution

  • 10190302019859 ()


  • Laboratory instrument/analyser application software IVD
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