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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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Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.
Siemens Healthcare Diagnostics Inc.
11065584
In Commercial Distribution

  • 00630414025148 ()
11065584

  • Coagulation analyser IVD, point-of-care, battery-powered
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER
Siemens Healthcare Diagnostics Inc.
11219531
In Commercial Distribution

  • 00630414019796 ()
11219531

  • Haematological cell analyser IVD
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH DUAL ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219529
In Commercial Distribution

  • 00630414019772 ()
11219529

  • Haematological cell analyser IVD
Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720846
In Commercial Distribution

  • 00630414016740 ()
10720846

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720849
In Commercial Distribution

  • 00630414016726 ()
10720849

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.
Siemens Healthcare Diagnostics Inc.
11046781
In Commercial Distribution

  • 00630414016627 ()
11046781

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Erythropoietin (EPO) - ADVIA Centaur - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995096
In Commercial Distribution

  • 00630414010380 ()
10995096

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
Aspartate Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097639
In Commercial Distribution

  • 00630414009063 ()
11097639

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
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