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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® Zika IgM Controls
Siemens Healthcare Diagnostics Inc.
11200111
Not in Commercial Distribution

  • 00630414170886 ()
11200111

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
ADVIA Centaur® Zika IgM Assay
Siemens Healthcare Diagnostics Inc.
11200103
Not in Commercial Distribution

  • 00630414170862 ()
11200103

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT).
Siemens Healthcare Diagnostics Inc.
10873633
In Commercial Distribution

  • 00630414170794 ()
10873633

  • Prothrombin time (PT) IVD, control
ADVIA Chemistry Systems 70-mL Wedges –Yellow
Siemens Healthcare Diagnostics Inc.
11223140
In Commercial Distribution

  • 00630414168258 ()
11223140

  • Assay container IVD, single-use
Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody IVD, control
Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311665
In Commercial Distribution

  • 00630414132075 ()
673702

  • Blood gas/haemoximetry analyser IVD, point-of-care
Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD
Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers
Siemens Healthcare Diagnostics Inc.
10327492
In Commercial Distribution

  • 00630414132013 ()
673396000

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLyte Multicap blood collection capillary tubes (50 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10323539
In Commercial Distribution

  • 00630414131986 ()
  • 00630414009520 ()
673394

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
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