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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DV/DM COV2G/CV2G CAL
Siemens Healthcare Diagnostics Inc.
11417772
Not in Commercial Distribution

  • 00630414298399 ()
  • 00630414607047 ()
KC872

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
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
Atellica CH EMPTY1
Siemens Healthcare Diagnostics Inc.
11538114
In Commercial Distribution

  • 00630414297651 ()
  • 00630414604664 ()
11538114

  • General laboratory assay tray
Atellica CH EMPTY2
Siemens Healthcare Diagnostics Inc.
11538115
In Commercial Distribution

  • 00630414297682 ()
  • 00630414604503 ()
11538115

  • General laboratory assay tray
Androstenedione (Andro) ADVIA Centaur - RGT 50T
Siemens Healthcare Diagnostics Inc.
10997290
In Commercial Distribution

  • 00630414603445 ()
10997290

  • Androstenedione IVD, kit, chemiluminescent immunoassay
Androstenedione (Andro) ADVIA Centaur - Master Curve Material 5x1x1.0mL
Siemens Healthcare Diagnostics Inc.
10997268
In Commercial Distribution

  • 00630414603438 ()
10997268

  • Androstenedione IVD, control
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