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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Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311576
In Commercial Distribution

  • 00630414124933 ()
672183000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Ferritin/VitB12 (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10334728
In Commercial Distribution

  • 00630414124926 ()
672182005

  • Multiple anaemia-related analyte IVD, calibrator
Ferritin/VitB12 - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10311575
In Commercial Distribution

  • 00630414124919 ()
672182000

  • Multiple anaemia-related analyte IVD, calibrator
CK-MB - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311570
In Commercial Distribution

  • 00630414124803 ()
672174000

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Calibrator D - 2 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311569
In Commercial Distribution

  • 00630414124797 ()
672173000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10311568
In Commercial Distribution

  • 00630414124780 ()
672172000

  • Multiple anaemia-related analyte IVD, calibrator
Cortisol Urin - CENTAUR - CTL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10318246
In Commercial Distribution

  • 00630414121819 ()
570408

  • Total cortisol IVD, reagent
For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10325104
In Commercial Distribution

  • 00630414118444 ()
  • 00630414009568 ()
478943000

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10323692
In Commercial Distribution

  • 00630414118383 ()
  • 00630414009537 ()
478941000

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
RAPIDLab® series Reference Electrode Fill Solution. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311081
In Commercial Distribution

  • 00630414117539 ()
  • 00630414010090 ()
478822

  • Ion selective electrode (ISE) reference solution IVD, reagent
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