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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 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

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® Systems HBeAg QC - 00630414531298

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

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 Centaur® Systems Calibrator 28 - 00630414527352

Valproic Acid - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10322227
Not in Commercial Distribution

  • 00630414527352 ()
5260521

  • Valproic acid therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems Calibrator 28 - 00630414527345

Valproic Acid - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322222
Not in Commercial Distribution

  • 00630414527345 ()
5259132

  • Valproic acid therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® VALP +28 - 00630414527338

Valproic Acid - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322218
Not in Commercial Distribution

  • 00630414527338 ()
  • 00630414027647 ()
5258292

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
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