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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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ARCHITECT - 00380740213831

ARCHITECT cSystems Assay Disk Conventional Units version 21.0
ABBOTT LABORATORIES
08G9824
In Commercial Distribution

  • 00380740213831 ()
08G9824

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213503

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 - 00380740213084

Alinity c ALT2F Assay File
Abbott GmbH
04T843B
In Commercial Distribution

  • 00380740213084 ()
04T843B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740213077

Alinity c ALT2 Assay File
Abbott GmbH
04T841B
In Commercial Distribution

  • 00380740213077 ()
04T841B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740212827

Alinity c Crea2 Urine Assay File
Abbott GmbH
04T913B
In Commercial Distribution

  • 00380740212827 ()
04T913B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740212810

Alinity c Crea2 Assay File
Abbott GmbH
04T911B
In Commercial Distribution

  • 00380740212810 ()
04T911B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740212803

Alinity c AlbBCP2 Assay File
Abbott GmbH
04T821B
In Commercial Distribution

  • 00380740212803 ()
04T821B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740212797

Alinity c AlbBCG2 Assay File
Abbott GmbH
04U301B
In Commercial Distribution

  • 00380740212797 ()
04U301B

  • Laboratory instrument/analyser application software IVD

AlinIQ - 00380740212575

AlinIQ AMS
ABBOTT SRL
03R8965
In Commercial Distribution

  • 00380740212575 ()
03R8965

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740211431

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
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