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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® FT4 - 00630414535425

Free T4 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10282219
In Commercial Distribution

  • 00630414535425 ()
  • 00630414002910 ()
6490106

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® FT4 - 00630414535418

Free T4 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282218
In Commercial Distribution

  • 00630414535418 ()
6490092

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® DHEA-S MCM - 00630414535340

DHEA-S Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10282214
In Commercial Distribution

  • 00630414535340 ()
6489752

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control

ADVIA Centaur® DHEAS - 00630414535333

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 Analyzer - 00630414534794

ADVIA® 1800 Instrument
Siemens Healthcare Diagnostics Inc.
10315183
In Commercial Distribution

  • 00630414534794 ()
073-A021-01

  • Multiple clinical chemistry analyser IVD, laboratory

ADVIA® Chemistry C-Reactive Protein_2 Calibrators - 00630414534244

CRP 2 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10337471
In Commercial Distribution

  • 00630414534244 ()
6487741

  • C-reactive protein (CRP) IVD, calibrator

ADVIA® Chemistry Microalbumin_2 Calibrators - 00630414534077

Microalbumin - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10337470
In Commercial Distribution

  • 00630414534077 ()
6487733

  • Microalbumin IVD, calibrator

Chek-Stix® Control+ strips - 00630414532844

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

Chek-Stix® Combo Pak Control+ Control- Strips - 00630414532837

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™ Systems Hemoglobin A1c Reagent Kit - 00630414532806

DCA HbA1c Test Kit (monitoring only) - INTL.
Siemens Healthcare Diagnostics Inc.
10311134
In Commercial Distribution

  • 00630414532806 ()
5035C

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
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