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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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Alinity c TCASQ1 Assay File
Abbott GmbH
09P915A
In Commercial Distribution

  • 00380740214371 ()
09P915A

  • Laboratory instrument/analyser application software IVD
Alinity c TBili2 Assay File
Abbott GmbH
04U051B
In Commercial Distribution

  • 00380740213978 ()
04U051B

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 29.0
ABBOTT LABORATORIES
04P5729
In Commercial Distribution

  • 00380740213862 ()
04P5729

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 28.0
ABBOTT LABORATORIES
04P5728
In Commercial Distribution

  • 00380740213855 ()
04P5728

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk SI Units version 21.0
ABBOTT LABORATORIES
04J6224
In Commercial Distribution

  • 00380740213848 ()
04J6224

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk Conventional Units version 21.0
ABBOTT LABORATORIES
08G9824
In Commercial Distribution

  • 00380740213831 ()
08G9824

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM – US Version 5.0
ABBOTT LABORATORIES
06R8905
In Commercial Distribution

  • 00380740213503 ()
06R8905

  • Laboratory instrument/analyser application software IVD
Alinity c ALT2F Assay File
Abbott GmbH
04T843B
In Commercial Distribution

  • 00380740213084 ()
04T843B

  • Laboratory instrument/analyser application software IVD
Alinity c ALT2 Assay File
Abbott GmbH
04T841B
In Commercial Distribution

  • 00380740213077 ()
04T841B

  • Laboratory instrument/analyser application software IVD
Alinity c Crea2 Urine Assay File
Abbott GmbH
04T913B
In Commercial Distribution

  • 00380740212827 ()
04T913B

  • Laboratory instrument/analyser application software IVD
Alinity c Crea2 Assay File
Abbott GmbH
04T911B
In Commercial Distribution

  • 00380740212810 ()
04T911B

  • Laboratory instrument/analyser application software IVD
Alinity c AlbBCP2 Assay File
Abbott GmbH
04T821B
In Commercial Distribution

  • 00380740212803 ()
04T821B

  • Laboratory instrument/analyser application software IVD
Alinity c AlbBCG2 Assay File
Abbott GmbH
04U301B
In Commercial Distribution

  • 00380740212797 ()
04U301B

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R8965
In Commercial Distribution

  • 00380740212575 ()
03R8965

  • Laboratory instrument/analyser application software IVD
ARCHITECT i100SR System e-Assay CD-ROM-US Version 27.0
ABBOTT LABORATORIES
04P5727
In Commercial Distribution

  • 00380740211431 ()
04P5727

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 26.0
ABBOTT LABORATORIES
04P5526
In Commercial Distribution

  • 00380740211424 ()
04P5526

  • Laboratory instrument/analyser application software IVD
Alinity c IgE-US Assay File
Abbott GmbH
01R133A
In Commercial Distribution

  • 00380740209544 ()
01R133A

  • Laboratory instrument/analyser application software IVD
Alinity i STAT High Sensitivity Troponin-I
Abbott GmbH
04Z211B
In Commercial Distribution

  • 00380740209438 ()
04Z211B

  • Laboratory instrument/analyser application software IVD
Alinity i UCH-L1 Assay File
Abbott GmbH
04W191B
In Commercial Distribution

  • 00380740208936 ()
04W191B

  • Laboratory instrument/analyser application software IVD
Alinity i GFAP Assay File
Abbott GmbH
04W171B
In Commercial Distribution

  • 00380740208929 ()
04W171B

  • Laboratory instrument/analyser application software IVD
Alinity i TBI Assay File
Abbott GmbH
04Z231B
In Commercial Distribution

  • 00380740208912 ()
04Z231B

  • Laboratory instrument/analyser application software IVD
Alinity c %A1cWB Assay File
Abbott GmbH
08P435D
In Commercial Distribution

  • 00380740204112 ()
08P435D

  • Laboratory instrument/analyser application software IVD
Alinity c A1cWB Assay File
Abbott GmbH
08P433D
In Commercial Distribution

  • 00380740204105 ()
08P433D

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 25.0
ABBOTT LABORATORIES
04P5525
In Commercial Distribution

  • 00380740204082 ()
04P5525

  • Laboratory instrument/analyser application software IVD
MULTIGENT SI / Alternate Units Assay Disk Version 10.0
ABBOTT LABORATORIES
08K5110
In Commercial Distribution

  • 00380740203399 ()
08K5110

  • Laboratory instrument/analyser application software IVD
MULTIGENT Conventional / Alternate Units Assay Disk Version 10.0
ABBOTT LABORATORIES
08K5010
In Commercial Distribution

  • 00380740203382 ()
08K5010

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgNx_C2 Assay File
Abbott GmbH
01R659A
In Commercial Distribution

  • 00380740202910 ()
01R659A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgNx_C1 Assay File
Abbott GmbH
01R658A
In Commercial Distribution

  • 00380740202903 ()
01R658A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgNx_%N Assay File
Abbott GmbH
01R657A
In Commercial Distribution

  • 00380740202897 ()
01R657A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgNx_ Assay File
Abbott GmbH
01R643A
In Commercial Distribution

  • 00380740202880 ()
01R643A

  • Laboratory instrument/analyser application software IVD
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