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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 Centaur® Systems, ACS:180® Systems CAL Calibrator Z - 00630414527154

Carbamazepine ADVIA CENTAUR2PK - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322039
Not in Commercial Distribution

  • 00630414527154 ()
5165359

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® CARB +Z - 00630414527147

Carbamazepine - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322035
Not in Commercial Distribution

  • 00630414527147 ()
  • 00630414027630 ()
5163003

  • Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CARB - 00630414527130

Carbamazepine - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322033
Not in Commercial Distribution

  • 00630414527130 ()
5162724

  • Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry sBNZ Serum Benzodiazepine Reagents - 00630414526928

Benzodiazepines - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10335939
Not in Commercial Distribution

  • 00630414526928 ()
5042192

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry sBRB Serum Barbiturate Reagents - 00630414526911

Barbiturates - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10335934
Not in Commercial Distribution

  • 00630414526911 ()
5040084

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry METMTB Methadone Metabolite Reagents - 00630414526904

TBD
Siemens Healthcare Diagnostics Inc.
10335933
Not in Commercial Distribution

  • 00630414526904 ()
5038055

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry CardioPhase™ hsCRP Calibrators - 00630414526843

CRP (High Sensitivity) Level 6 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10335897
In Commercial Distribution

  • 00630414526843 ()
5006455

  • C-reactive protein (CRP) IVD, calibrator

ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent - 00630414526829

Triglyceride - ADVIA Chem. - RGT - 4x358/4x362 tests
Siemens Healthcare Diagnostics Inc.
10335892
In Commercial Distribution

  • 00630414526829 ()
  • 00630414003733 ()
5001860

  • Triglyceride IVD, kit, spectrophotometry

ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents - 00630414526812

Glucose - ADVIA Chem. - RGT - 6x660/6x470 tests
Siemens Healthcare Diagnostics Inc.
10335891
In Commercial Distribution

  • 00630414526812 ()
5001429

  • Glucose IVD, kit, spectrophotometry

ADVIA® Chemistry UPRO_2 Total Protein_2 (Urine) Reagents - 00630414526782

Protein - ADVIA Chem. - RGT - 4x194 tests
Siemens Healthcare Diagnostics Inc.
10335885
Not in Commercial Distribution

  • 00630414526782 ()
  • 00630414003726 ()
5000171

  • Total protein IVD, kit, enzyme spectrophotometry
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