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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High-Sensitvity Troponin Calibrator Dimension Vista - CAL 5 Levels 2 VL/Level
Siemens Healthcare Diagnostics Inc.
10719482
In Commercial Distribution

  • 00630414180373 ()
  • 00630414225210 ()
KC627

  • Troponin I IVD, calibrator
Myoglobin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310001
In Commercial Distribution

  • 00630414180014 ()
111543

  • Myoglobin IVD, control
Multidil 11 - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10309999
In Commercial Distribution

  • 00630414178547 ()
111088

  • Buffered sample diluent IVD
Myoglobin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309996
In Commercial Distribution

  • 00630414178493 ()
111083

  • Myoglobin IVD, calibrator
Testosterone - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309989
Not in Commercial Distribution

  • 00630414177519 ()
110782

  • Total testosterone IVD, kit, chemiluminescent immunoassay
IgE - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309986
In Commercial Distribution

  • 00630414177489 ()
  • 00630414003269 ()
110778

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309985
In Commercial Distribution

  • 00630414177472 ()
110777

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
CKMB Mass - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10326496
In Commercial Distribution

  • 00630414177441 ()
  • 00630414003627 ()
110774

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CKMB Mass - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309982
In Commercial Distribution

  • 00630414177434 ()
110773

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Digoxin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322129
In Commercial Distribution

  • 00630414177427 ()
  • 00630414003566 ()
110772

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
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