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 PCPQ Assay File
Abbott GmbH
09P661A
In Commercial Distribution

  • 00380740170431 ()
09P661A

  • Laboratory instrument/analyser application software IVD
Alinity c Opi6SQ Assay File
Abbott GmbH
09P657A
In Commercial Distribution

  • 00380740170424 ()
09P657A

  • Laboratory instrument/analyser application software IVD
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
BD FACSuite™ Clinical BD Leucocount™ Assay Module
Becton, Dickinson And Company
665732
In Commercial Distribution

  • 00382906657329 ()
665732

  • Laboratory instrument/analyser application software IVD
BD FACSDiva™ v9.0.1
Becton, Dickinson And Company
664345
In Commercial Distribution

  • 00382906643452 ()
664345

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical, BD Multitest™ 6-Color Assays
Becton, Dickinson And Company
664237
In Commercial Distribution

  • 00382906642370 ()
664237

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical, BD Multitest™ 4-Color Assays
Becton, Dickinson And Company
664236
In Commercial Distribution

  • 00382906642363 ()
664236

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical Application
Becton, Dickinson And Company
664235
In Commercial Distribution

  • 00382906642356 ()
664235

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical BD Multitest™ 4-Color Assays v1.0
Becton, Dickinson And Company
663005
In Commercial Distribution

  • 00382906630056 ()
663005

  • Laboratory instrument/analyser application software IVD
FACSCanto 3.0 SW without dongle
BECTON, DICKINSON AND COMPANY
657770
Not in Commercial Distribution

  • 00382906577702 ()
657770

  • Laboratory instrument/analyser application software IVD
BD FACSCANTO System SW V3.0 W/Dongle
BECTON, DICKINSON AND COMPANY
657766
Not in Commercial Distribution

  • 00382906577665 ()
657766

  • Laboratory instrument/analyser application software IVD
FACSCanto V2.4 SW With Dongle
BECTON, DICKINSON AND COMPANY
657081
Not in Commercial Distribution

  • 00382906570819 ()
657081

  • Laboratory instrument/analyser application software IVD
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