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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 - 00380740151461

Alinity i A-HBsDilUS Assay File
Abbott GmbH
07P883A
In Commercial Distribution

  • 00380740151461 ()
07P883A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740151447

Alinity i VitB12 Assay File
Abbott GmbH
07P673A
In Commercial Distribution

  • 00380740151447 ()
07P673A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740151430

Alinity i Anti-TPO Assay File
Abbott GmbH
09P351A
In Commercial Distribution

  • 00380740151430 ()
09P351A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740151423

Alinity i Anti-Tg Assay File
Abbott GmbH
09P341A
In Commercial Distribution

  • 00380740151423 ()
09P341A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740151416

Alinity i Anti-CCP Assay File
Abbott GmbH
09P271A
In Commercial Distribution

  • 00380740151416 ()
09P271A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740151409

Alinity i Active B12 Assay File
Abbott GmbH
09P261A
In Commercial Distribution

  • 00380740151409 ()
09P261A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740150914

Alinity i Testo 2G Assay File
Abbott GmbH
07P683A
In Commercial Distribution

  • 00380740150914 ()
07P683A

  • Laboratory instrument/analyser application software IVD

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

Alinity - 00380740146597

Alinity i CA 15-3 Assay File
Abbott GmbH
08P511A
In Commercial Distribution

  • 00380740146597 ()
08P511A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146580

Alinity i CA19-9XR Assay File
Abbott GmbH
08P321A
In Commercial Distribution

  • 00380740146580 ()
08P321A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740146436

Alinity i Cortisol Assay File
Abbott GmbH
08P331A
In Commercial Distribution

  • 00380740146436 ()
08P331A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740145194

ARCHITECT TBili Conv Units e-Assay CD-ROM
ABBOTT LABORATORIES
7P32-1A
In Commercial Distribution

  • 00380740145194 ()
07P321A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740145156

ARCHITECT TBili SI Units e- Assay CD-ROM
ABBOTT LABORATORIES
7P32-3A
In Commercial Distribution

  • 00380740145156 ()
07P323A

  • Laboratory instrument/analyser application software IVD

AlinIQ - 00380740145125

AlinIQ AMS
ABBOTT SRL
03R89-24
In Commercial Distribution

  • 00380740145125 ()
03R8924

  • Laboratory instrument/analyser application software IVD

AlinIQ - 00380740145118

AlinIQ AMS
ABBOTT SRL
03R89-23
In Commercial Distribution

  • 00380740145118 ()
03R8923

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143466

Alinity c Vancomycin Assay File
Abbott GmbH
08P521A
In Commercial Distribution

  • 00380740143466 ()
08P521A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143459

Alinity c U/CSF Prot Assay File
Abbott GmbH
07P591A
In Commercial Distribution

  • 00380740143459 ()
07P591A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143442

Alinity c Microalb Assay File
Abbott GmbH
08P041A
In Commercial Distribution

  • 00380740143442 ()
08P041A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143435

Alinity c Transf Assay File
Abbott GmbH
08P381A
In Commercial Distribution

  • 00380740143435 ()
08P381A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143411

Alinity c Salicylate Assay File
Abbott GmbH
08P591A
In Commercial Distribution

  • 00380740143411 ()
08P591A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143404

Alinity c Phenytoin Assay File
Abbott GmbH
08P541A
In Commercial Distribution

  • 00380740143404 ()
08P541A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143367

Alinity c LacticAcid Assay File
Abbott GmbH
08P211A
In Commercial Distribution

  • 00380740143367 ()
08P211A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143350

Alinity c Gentamicin Assay File
Abbott GmbH
08P551A
In Commercial Distribution

  • 00380740143350 ()
08P551A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143343

Alinity c Ethanol Assay File
Abbott GmbH
08P411A
In Commercial Distribution

  • 00380740143343 ()
08P411A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143336

Alinity c Direct LDL Assay File
Abbott GmbH
07P711A
In Commercial Distribution

  • 00380740143336 ()
07P711A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143329

Alinity c Digoxin Assay File
Abbott GmbH
08P371A
In Commercial Distribution

  • 00380740143329 ()
08P371A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143299

Alinity c CrEnzU Assay File
Abbott GmbH
08P013A
In Commercial Distribution

  • 00380740143299 ()
08P013A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143282

Alinity c CrEnz Assay File
Abbott GmbH
08P011A
In Commercial Distribution

  • 00380740143282 ()
08P011A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143275

Alinity c Cerulo Assay File
Abbott GmbH
09P931A
In Commercial Distribution

  • 00380740143275 ()
09P931A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143268

Alinity c Carb Assay File
Abbott GmbH
08P581A
In Commercial Distribution

  • 00380740143268 ()
08P581A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143251

Alinity c Bili D Assay File
Abbott GmbH
07P971A
In Commercial Distribution

  • 00380740143251 ()
07P971A

  • Laboratory instrument/analyser application software IVD
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