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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 PHNY_2 Phenytoin_2 Reagents - 00630414561936

Phenytoin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377506
In Commercial Distribution

  • 00630414561936 ()
10377506

  • Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry PHNB_2 Phenobarbital_2 Reagents - 00630414561929

Phenobarbital - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377505
In Commercial Distribution

  • 00630414561929 ()
10377505

  • Phenobarbital therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry THEO_2 Theophylline_2 Reagents - 00630414561905

Theophyline - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377503
In Commercial Distribution

  • 00630414561905 ()
10377503

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry GLUH_c Glucose Hexokinase_3 Reagents, Concentrated - 00630414561899

Glucose - ADVIA Chem. - Conc. RGT - 4x2100/4x1600 tests
Siemens Healthcare Diagnostics Inc.
10377502
In Commercial Distribution

  • 00630414561899 ()
10377502

  • Glucose IVD, kit, spectrophotometry

ADVIA Centaur® aHBs2 - 00630414561790

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10286268
In Commercial Distribution

  • 00630414561790 ()
4670661

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents - 00630414561677

Tobramycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376932
Not in Commercial Distribution

  • 00630414561677 ()
10376932

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry CYSC Cystatin-C Calibrators - 00630414561578

Cystatin C - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10376487
Not in Commercial Distribution

  • 00630414561578 ()
10376487

  • Cystatin C IVD, calibrator

ADVIA® Chemistry Drug Calibrator II - 00630414561332

Drug 2 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376771
Not in Commercial Distribution

  • 00630414561332 ()
10376771

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry Drug Calibrator I - 00630414561325

Drug 1 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376770
In Commercial Distribution

  • 00630414561325 ()
10376770

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® HBcT2 Quality Control Kit - 00630414561233

ADVIA Centaur® HBcT2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10376699
In Commercial Distribution

  • 00630414210766 ()
  • 00630414561233 ()
10376699

  • Hepatitis B virus core total antibody IVD, control
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