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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 - 00380740211424

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 - 00380740209544

Alinity c IgE-US Assay File
Abbott GmbH
01R133A
In Commercial Distribution

  • 00380740209544 ()
01R133A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740209438

Alinity i STAT High Sensitivity Troponin-I
Abbott GmbH
04Z211B
In Commercial Distribution

  • 00380740209438 ()
04Z211B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740208936

Alinity i UCH-L1 Assay File
Abbott GmbH
04W191B
In Commercial Distribution

  • 00380740208936 ()
04W191B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740208929

Alinity i GFAP Assay File
Abbott GmbH
04W171B
In Commercial Distribution

  • 00380740208929 ()
04W171B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740208912

Alinity i TBI Assay File
Abbott GmbH
04Z231B
In Commercial Distribution

  • 00380740208912 ()
04Z231B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740204112

Alinity c %A1cWB Assay File
Abbott GmbH
08P435D
In Commercial Distribution

  • 00380740204112 ()
08P435D

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740204105

Alinity c A1cWB Assay File
Abbott GmbH
08P433D
In Commercial Distribution

  • 00380740204105 ()
08P433D

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740204082

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

ARCHITECT - 00380740203399

MULTIGENT SI / Alternate Units Assay Disk Version 10.0
ABBOTT LABORATORIES
08K5110
In Commercial Distribution

  • 00380740203399 ()
08K5110

  • Laboratory instrument/analyser application software IVD
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