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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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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 Microalbumin Creatinine Reagent Kit - 00630414532790

DCA Microablumin Creatinine Test Kit (ACR test).
Siemens Healthcare Diagnostics Inc.
10311480
In Commercial Distribution

  • 00630414532790 ()
6011A

  • Microalbumin IVD, kit, spectrophotometry

ADVIA Centaur® VALP MCM - 00630414527369

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

ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent - 00630414526829

Triglyceride - ADVIA Chem. - RGT - 4x358/4x362 tests
Siemens Healthcare Diagnostics Inc.
10335892
In Commercial Distribution

  • 00630414526829 ()
  • 00630414003733 ()
5001860

  • Triglyceride IVD, kit, spectrophotometry

ADVIA® Chemistry ISE Buffer - 00630414526768

ISE Buffer Large - ADVIA Chem. - CONS - 3 Liter
Siemens Healthcare Diagnostics Inc.
10321715
In Commercial Distribution

  • 00630414526768 ()
4997873

  • pH-adjusted buffer solution IVD

ADVIA® Chemistry CHOL_c Cholesterol Reagents, Concentrated - 00630414526744

Cholesterol - ADVIA Chem. - Conc. RGT - 4x2100/4x1340 tests
Siemens Healthcare Diagnostics Inc.
10335874
In Commercial Distribution

  • 00630414526744 ()
  • 00630414003719 ()
4993681

  • Total cholesterol lipid IVD, kit, spectrophotometry

ADVIA® Chemistry UA_c Uric Acid Reagents, Concentrated - 00630414526737

Uric Acid - ADVIA Chem. - RGT - 6x1250 tests
Siemens Healthcare Diagnostics Inc.
10335873
In Commercial Distribution

  • 00630414526737 ()
4993452

  • Uric acid IVD, kit, spectrophotometry

ADVIA® Chemistry MG_c Magnesium Reagents, Concentrated - 00630414526713

Magnesium - ADVIA Chem. - RGT - 6x1270 tests
Siemens Healthcare Diagnostics Inc.
10335871
In Commercial Distribution

  • 00630414526713 ()
4992960

  • Magnesium (Mg2+) IVD, kit, spectrophotometry

ADVIA Centaur® COR MCM - 00630414524740

Cortisol - Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309080
In Commercial Distribution

  • 00630414524740 ()
4639454

  • Total cortisol IVD, control
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