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 Class Implantable

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Multidil 1 Readypack(2PK) - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10309941
In Commercial Distribution

  • 00630414175218 ()
  • 00630414003078 ()
110312

  • Buffered sample diluent IVD
A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge.
Siemens Healthcare Diagnostics Inc.
10888741
In Commercial Distribution

  • 00630414171142 ()
  • 00630414211039 ()
10888741

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
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
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