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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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ADVIA® Chemistry GGT Reagents - 00630414209753

GGT - ADVIA Chem. - RGT - 4x675 tests
Siemens Healthcare Diagnostics Inc.
10316298
In Commercial Distribution

  • 00630414209753 ()
B01-4138-01

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

ADVIA® Chemistry CKNAC Creatine Kinase Reagents - 00630414209746

CK - ADVIA Chem. - RGT - 4x270 tests
Siemens Healthcare Diagnostics Inc.
10341111
Not in Commercial Distribution

  • 00630414209746 ()
  • 00630414003740 ()
B01-4137-01

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

Dimension VIsta TNIH Calibrator - 00630414180373

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

ADVIA Centaur® MYO MCM - 00630414180014

Myoglobin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310001
In Commercial Distribution

  • 00630414180014 ()
111543

  • Myoglobin IVD, control

ADVIA Centaur® ACS:180®DIL Multi-Diluent 11 - 00630414178547

Multidil 11 - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10309999
In Commercial Distribution

  • 00630414178547 ()
111088

  • Buffered sample diluent IVD

ADVIA Centaur® ACS:180® Calibrator U - 00630414178493

Myoglobin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309996
In Commercial Distribution

  • 00630414178493 ()
111083

  • Myoglobin IVD, calibrator

ADVIA Centaur® TSTO - 00630414177519

Testosterone - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309989
Not in Commercial Distribution

  • 00630414177519 ()
110782

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® tIgE - 00630414177489

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

ADVIA Centaur® tIgE - 00630414177472

IgE - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309985
In Commercial Distribution

  • 00630414177472 ()
110777

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CKMB - 00630414177441

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
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