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 i POSTM_ROMA Assay File
Abbott GmbH
03R753A
In Commercial Distribution

  • 00380740146634 ()
03R753A

  • Laboratory instrument/analyser application software IVD
Alinity i PREM_ROMA Assay File
Abbott GmbH
03R751A
In Commercial Distribution

  • 00380740146627 ()
03R751A

  • Laboratory instrument/analyser application software IVD
Alinity i HE4 Assay File
Abbott GmbH
08P501A
In Commercial Distribution

  • 00380740146610 ()
08P501A

  • Laboratory instrument/analyser application software IVD
Alinity i CA 125 II Assay File
Abbott GmbH
08P491A
In Commercial Distribution

  • 00380740146603 ()
08P491A

  • Laboratory instrument/analyser application software IVD
Alinity i CA 15-3 Assay File
Abbott GmbH
08P511A
In Commercial Distribution

  • 00380740146597 ()
08P511A

  • Laboratory instrument/analyser application software IVD
Alinity i CA19-9XR Assay File
Abbott GmbH
08P321A
In Commercial Distribution

  • 00380740146580 ()
08P321A

  • Laboratory instrument/analyser application software IVD
Alinity i Cortisol Assay File
Abbott GmbH
08P331A
In Commercial Distribution

  • 00380740146436 ()
08P331A

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R89-24
In Commercial Distribution

  • 00380740145125 ()
03R8924

  • Laboratory instrument/analyser application software IVD
Alinity c AmylaseU Assay File
Abbott GmbH
07P583A
In Commercial Distribution

  • 00380740143244 ()
07P583A

  • Laboratory instrument/analyser application software IVD
Alinity c Ammonia Assay File
Abbott GmbH
08P221A
In Commercial Distribution

  • 00380740143220 ()
08P221A

  • Laboratory instrument/analyser application software IVD
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