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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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ARCHITECT - 00380740194826

ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM-US Version 4.0
ABBOTT LABORATORIES
06R8904
In Commercial Distribution

  • 00380740194826 ()
06R8904

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740194758

Alinity i HSV-1 IgG Assay File
Abbott GmbH
04W201A
In Commercial Distribution

  • 00380740194758 ()
04W201A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740194208

Alinity c BenzSQ Assay File
Abbott GmbH
09P523B
In Commercial Distribution

  • 00380740194208 ()
09P523B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740194192

Alinity c BenzQ Assay File
Abbott GmbH
09P521B
In Commercial Distribution

  • 00380740194192 ()
09P521B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740194093

Alinity i COV 2IgGII Assay File
Abbott GmbH
06S611A
In Commercial Distribution

  • 00380740194093 ()
06S611A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740193638

Alinity i STAT High Sensitivity Tropopnin-I
Abbott GmbH
04Z211A
In Commercial Distribution

  • 00380740193638 ()
04Z211A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740193577

Alinity i Free T4 Assay File
Abbott GmbH
07P701B
In Commercial Distribution

  • 00380740193577 ()
07P701B

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740192846

ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM-US Version 3.0
ABBOTT LABORATORIES
06R8903
In Commercial Distribution

  • 00380740192846 ()
06R8903

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740192761

ARCHITECT i1000SR System e-Assay CD-ROM-US Version 25.0
ABBOTT LABORATORIES
04P5725
In Commercial Distribution

  • 00380740192761 ()
04P5725

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740192754

ARCHITECT i System e-Assay CD-ROM-US Version 23.0
ABBOTT LABORATORIES
04P5523
In Commercial Distribution

  • 00380740192754 ()
04P5523

  • Laboratory instrument/analyser application software IVD
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