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 Class Implantable

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Zika Ab ADVIA Centaur Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
11202473
In Commercial Distribution

  • 00630414247021 ()
11202473

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Zika IgM ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11202472
In Commercial Distribution

  • 00630414247014 ()
11202472

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Zika IgM ADVIA Centaur Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11202471
In Commercial Distribution

  • 00630414247007 ()
11202471

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
CMV IgG Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202208
In Commercial Distribution

  • 00630414246635 ()
11202208

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL/vial
Siemens Healthcare Diagnostics Inc.
11202700
In Commercial Distribution

  • 00630414246567 ()
  • 00630414246581 ()
11202700

  • Procalcitonin (PCT) IVD, control
Procalcitonin (PCT) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11202699
In Commercial Distribution

  • 00630414246550 ()
11202699

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
CMV IgG Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
11202209
In Commercial Distribution

  • 00630414246482 ()
  • 00630414283920 ()
11202209

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
Erythropoietin (EPO) QC Kit - Atellica IM - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733008
In Commercial Distribution

  • 00630414245799 ()
10733008

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) - Atellica IM - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10733007
In Commercial Distribution

  • 00630414245782 ()
10733007

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733006
In Commercial Distribution

  • 00630414245775 ()
10733006

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
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