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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 CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III - 00630414553160

Calcium - ADVIA Chem. - RGT - 4x1700 tests
Siemens Healthcare Diagnostics Inc.
10283344
In Commercial Distribution

  • 00630414553160 ()
  • 00630414002941 ()
6860493

  • Calcium (Ca2+) IVD, kit, spectrophotometry

ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated - 00630414553153

AST/GOT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283343
In Commercial Distribution

  • 00630414553153 ()
6860485

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents - 00630414553146

ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283342
Not in Commercial Distribution

  • 00630414553146 ()
  • 00630414002934 ()
6860477

  • Alanine aminotransferase (ALT) IVD, reagent

ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated - 00630414553139

ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283341
In Commercial Distribution

  • 00630414553139 ()
6860469

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein - 00630414552699

CRP Cardiophase - ADVIA Chem. - RGT - 2x220 tests
Siemens Healthcare Diagnostics Inc.
10283282
In Commercial Distribution

  • 00630414552699 ()
6837459

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry CRP_2 Reagents - 00630414552118

CRP - ADVIA Chem. - RGT - 4x250 tests
Siemens Healthcare Diagnostics Inc.
10283129
In Commercial Distribution

  • 00630414552118 ()
6522059

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents - 00630414551784

HDL Cholesterol - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10283089
In Commercial Distribution

  • 00630414551784 ()
6521559

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

ADVIA Centaur® Systems aHBs2 QC - 00630414551777

Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® SHBG - 00630414551548

SHBG - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10283087
Not in Commercial Distribution

  • 00630414551548 ()
6520781

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® SHBG MCM - 00630414551531

SHBG Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10283086
Not in Commercial Distribution

  • 00630414551531 ()
6520773

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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