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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Creatinine Jaffe - ADVIA Chem. - Conc. RGT - 4x2360 tests
Siemens Healthcare Diagnostics Inc.
10283346
In Commercial Distribution

  • 00630414553184 ()
6860515

  • Creatinine IVD, kit, spectrophotometry
CO2 enzymatic - ADVIA Chem. - Conc. RGT - 7520 tests
Siemens Healthcare Diagnostics Inc.
10283345
In Commercial Distribution

  • 00630414553177 ()
  • 00630414002958 ()
6860507

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
Calcium - ADVIA Chem. - RGT - 4x1700 tests
Siemens Healthcare Diagnostics Inc.
10283344
In Commercial Distribution

  • 00630414553160 ()
  • 00630414002941 ()
6860493

  • Calcium (Ca2+) IVD, kit, spectrophotometry
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
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
ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283341
In Commercial Distribution

  • 00630414553139 ()
6860469

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
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
CRP - ADVIA Chem. - RGT - 4x250 tests
Siemens Healthcare Diagnostics Inc.
10283129
In Commercial Distribution

  • 00630414552118 ()
6522059

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
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
Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control
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