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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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SARS-CoV-2 IgG Calibrator Kit
ABBOTT LABORATORIES
06R8601
In Commercial Distribution

  • 00380740191818 ()
06R8601

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Alinity s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg Confirmatory e-Assay File
Abbott GmbH
06P035A
In Commercial Distribution

  • 00380740162931 ()
06P035A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg e-Assay File
Abbott GmbH
06P025A
In Commercial Distribution

  • 00380740162924 ()
06P025A

  • Laboratory instrument/analyser application software IVD
Alinity s Anti-HBc e-Assay File
Abbott GmbH
06P065A
In Commercial Distribution

  • 00380740162917 ()
06P065A

  • Laboratory instrument/analyser application software IVD
Alinity s Anti-HCV e-Assay File
Abbott GmbH
06P045A
In Commercial Distribution

  • 00380740162894 ()
06P045A

  • Laboratory instrument/analyser application software IVD
Alinity s HIV Ag/Ab Combo e-Assay File
Abbott GmbH
06P015A
In Commercial Distribution

  • 00380740162887 ()
06P015A

  • Laboratory instrument/analyser application software IVD
Alinity s Chagas e-Assay File
Abbott GmbH
06P085A
In Commercial Distribution

  • 00380740162863 ()
06P085A

  • Laboratory instrument/analyser application software IVD
Alinity s Maintenance Cleaning Kit
ABBOTT LABORATORIES
04R7050
In Commercial Distribution

  • 00380740156817 ()
  • 00380740167776 ()
04R7050

  • Chemiluminescent immunoassay analyser IVD
Alinity s System
ABBOTT LABORATORIES
06P1601
In Commercial Distribution

  • 00380740138479 ()
06P1601

  • Chemiluminescent immunoassay analyser IVD
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