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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ADVIA Centaur® Calibrator G (2-pack)
Siemens Healthcare Diagnostics Inc.
10337319
In Commercial Distribution

  • 00630414194707 ()
116152

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill Solution for in vitro diagnostic use on RAPIDLab® 348/348EX analyzers
Siemens Healthcare Diagnostics Inc.
10311047
In Commercial Distribution

  • 00630414194455 ()
  • 00630414010076 ()
478535

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Total HCG Diluent - CENTAUR - CAL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10310213
In Commercial Distribution

  • 00630414190969 ()
115249

  • Buffered sample diluent IVD
Wash 1 Reagent - CENTAUR - CAL - 2x1500mL
Siemens Healthcare Diagnostics Inc.
10310032
In Commercial Distribution

  • 00630414187273 ()
  • 00630414003276 ()
112351

  • Buffered wash solution IVD
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
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
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
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
LOCI Anemia Calibrator, 2 X 5 X 1.0 mL
Siemens Healthcare Diagnostics Inc.
10463372
In Commercial Distribution

  • 00630414976631 ()
RC640

  • Multiple anaemia-related analyte IVD, calibrator
LOCI Vitamin B12 Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463371
In Commercial Distribution

  • 00630414976624 ()
  • 00630414005508 ()
RF642

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
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