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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Siemens Healthcare Diagnostics Inc.
10995083
In Commercial Distribution

  • 00630414010472 ()
10995083

  • Interleukin-6 (IL-6) IVD, control
ADVIA Centaur ® IL-6 100T Kit
Siemens Healthcare Diagnostics Inc.
10995080
In Commercial Distribution

  • 00630414010434 ()
10995080

  • Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® Zika IgM Controls
Siemens Healthcare Diagnostics Inc.
11200111
Not in Commercial Distribution

  • 00630414170886 ()
11200111

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
ADVIA Centaur® Zika IgM Assay
Siemens Healthcare Diagnostics Inc.
11200103
Not in Commercial Distribution

  • 00630414170862 ()
11200103

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Vista COV2G Assay
Siemens Healthcare Diagnostics Inc.
11417771
Not in Commercial Distribution

  • 00630414298382 ()
  • 00630414607139 ()
K7771

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Dimension CV2G Assay
Siemens Healthcare Diagnostics Inc.
11417770
Not in Commercial Distribution

  • 00630414298375 ()
  • 00630414607030 ()
RF870

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
DV/DM COV2T/CV2T CAL
Siemens Healthcare Diagnostics Inc.
11417413
Not in Commercial Distribution

  • 00630414297606 ()
  • 00630414605494 ()
KC813

  • SARS-CoV-2 total antibody IVD, calibrator
DV/DM COV2T/CV2T POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417415
Not in Commercial Distribution

  • 00630414297620 ()
  • 00630414605425 ()
KC815

  • SARS-CoV-2 total antibody IVD, control
Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
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