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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 - 00380740150150

ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-20
Not in Commercial Distribution

  • 00380740150150 ()
04P5720

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740150143

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-17
Not in Commercial Distribution

  • 00380740150143 ()
04P5517

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740146689

ARCHITECT UIBC-L SI Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-3A
In Commercial Distribution

  • 00380740146689 ()
04R293A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740146672

ARCHITECT UIBC-L Conv Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-1A
In Commercial Distribution

  • 00380740146672 ()
04R291A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146665

Alinity i iPTH Stat Assay File
Abbott GmbH
08P313A
In Commercial Distribution

  • 00380740146665 ()
08P313A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146658

Alinity i iPTH Assay File
Abbott GmbH
08P311A
In Commercial Distribution

  • 00380740146658 ()
08P311A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146634

Alinity i POSTM_ROMA Assay File
Abbott GmbH
03R753A
In Commercial Distribution

  • 00380740146634 ()
03R753A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146627

Alinity i PREM_ROMA Assay File
Abbott GmbH
03R751A
In Commercial Distribution

  • 00380740146627 ()
03R751A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146610

Alinity i HE4 Assay File
Abbott GmbH
08P501A
In Commercial Distribution

  • 00380740146610 ()
08P501A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146603

Alinity i CA 125 II Assay File
Abbott GmbH
08P491A
In Commercial Distribution

  • 00380740146603 ()
08P491A

  • Laboratory instrument/analyser application software IVD
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