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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® VB12 MCM - 00630414054124

Vitamin B12 - Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309760
In Commercial Distribution

  • 00630414054124 ()
104523

  • Vitamin B12 IVD, control

Emit II Plus Oxycodone Positive Control 100 - 00630414027999

Emit II Plus Oxycodone Positive Control 100
Siemens Healthcare Diagnostics Inc.
10720810
In Commercial Distribution

  • 00630414027999 ()
9T619UL

  • Oxycodone IVD, control

Emit II Plus Oxycodone Positive Control 300 - 00630414027975

Emit II Plus Oxycodone Positive Control 300
Siemens Healthcare Diagnostics Inc.
10720812
In Commercial Distribution

  • 00630414027975 ()
9T719UL

  • Oxycodone IVD, control

DCA® Systems Microalbumin/Creatinine Capillary holders and plungers - 00630414027364

A urine collection tube holder and plunger; to be used with DCA® Systems Microalbumin/Creatinine Reagent Cartridge.
Siemens Healthcare Diagnostics Inc.
10888739
In Commercial Distribution

  • 00630414027364 ()
  • 00630414211022 ()
10888739

  • Capillary blood collection tube IVD, no additive

ADVIA Centaur Herpes-1 IgG Quality Control - 00630414016757

Herpes-1 IgG (HSV1) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720847
In Commercial Distribution

  • 00630414016757 ()
10720847

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur Herpes-2 IgG Quality Control - 00630414016733

Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720850
In Commercial Distribution

  • 00630414016733 ()
10720850

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

Atellica IM PCT MCM - 00630414014197

Procalcitonin (PCT) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998265
In Commercial Distribution

  • 00630414014197 ()
10998265

  • Procalcitonin (PCT) IVD, control

Dimension® EXL™ with LM Integrated Chemistry System - 00630414014135

Dimension® EXL™ with LM Integrated Chemistry System with Reagent Management System (RMS) and Sample Transfer Module (STM)
Siemens Healthcare Diagnostics Inc.
10718149
In Commercial Distribution

  • 00630414014135 ()
759020.911

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension® EXL™ with LM Integrated Chemistry System - 00630414014128

Dimension® EXL™ with LM integrated chemistry system with Reagent Management System (RMS)
Siemens Healthcare Diagnostics Inc.
10475506
In Commercial Distribution

  • 00630414014128 ()
778020.911

  • Multiple clinical chemistry analyser IVD, laboratory

ADVIA Centaur EPO Quality Control - 00630414010403

Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10995099
In Commercial Distribution

  • 00630414010403 ()
10995099

  • Erythropoietin (EPO) IVD, control
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