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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Phenytoin - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10314977
Not in Commercial Distribution

  • 00630414121772 ()
570404

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Phenytoin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311391
Not in Commercial Distribution

  • 00630414121765 ()
570403

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Phenytoin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311390
Not in Commercial Distribution

  • 00630414121758 ()
570402

  • Phenytoin therapeutic drug monitoring IVD, control
For in vitro diagnostic use for verifying glucose and lactate sensor performance on the RAPIDLab® 1260 & 1265 systems
Siemens Healthcare Diagnostics Inc.
10311387
In Commercial Distribution

  • 00630414121628 ()
  • 00630414024516 ()
570097

  • Multiple blood gas analyte IVD, calibrator
Vancomycin - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10330624
Not in Commercial Distribution

  • 00630414121451 ()
570062

  • Vancomycin therapeutic drug monitoring IVD, calibrator
Vancomycin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311377
Not in Commercial Distribution

  • 00630414121444 ()
570061

  • Vancomycin therapeutic drug monitoring IVD, calibrator
Ready Sensor™ Glucose Biosensor for use on the Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Glucose WarrantyReaplacement
Siemens Healthcare Diagnostics Inc.
10312818
In Commercial Distribution

  • 00630414121154 ()
570024

  • Glucose IVD, kit, ion-selective electrode (ISE)
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.
10341140
In Commercial Distribution

  • 00630414118413 ()
  • 00630414009742 ()
478942000

  • 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
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