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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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DHEA-S - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282227
In Commercial Distribution

  • 00630414535333 ()
6489701

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
ADVIA® 1800 Instrument
Siemens Healthcare Diagnostics Inc.
10315183
In Commercial Distribution

  • 00630414534794 ()
073-A021-01

  • Multiple clinical chemistry analyser IVD, laboratory
CRP 2 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10337471
In Commercial Distribution

  • 00630414534244 ()
6487741

  • C-reactive protein (CRP) IVD, calibrator
Microalbumin - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10337470
In Commercial Distribution

  • 00630414534077 ()
6487733

  • Microalbumin IVD, calibrator
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive strips
Siemens Healthcare Diagnostics Inc.
10310482
In Commercial Distribution

  • 00630414532844 ()
  • 00630414009230 ()
1360

  • Multiple urine analyte IVD, control
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive and 25 negative strips
Siemens Healthcare Diagnostics Inc.
10310483
In Commercial Distribution

  • 00630414532837 ()
1364

  • Multiple urine analyte IVD, control
DCA HbA1c Test Kit (monitoring only) - INTL.
Siemens Healthcare Diagnostics Inc.
10311134
In Commercial Distribution

  • 00630414532806 ()
5035C

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
DCA Microablumin Creatinine Test Kit (ACR test).
Siemens Healthcare Diagnostics Inc.
10311480
In Commercial Distribution

  • 00630414532790 ()
6011A

  • Microalbumin IVD, kit, spectrophotometry
Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control
Valproic Acid Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322232
Not in Commercial Distribution

  • 00630414527369 ()
5261307

  • Valproic acid therapeutic drug monitoring IVD, control
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