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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Myoglobin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310277
In Commercial Distribution

  • 00630414197180 ()
117030

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Calibrating Gas Kit for Siemens Healthcare Diagnostics Blood Gas Systems that use gas regulators without metering valves.
Siemens Healthcare Diagnostics Inc.
10318934
In Commercial Distribution

  • 00630414196701 ()
116769

  • Multiple blood gas analyte IVD, calibrator
BR Pretreatment - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310272
In Commercial Distribution

  • 00630414196688 ()
  • 00630414003290 ()
116746

  • Cancer antigen 27-29 (CA27-29) IVD, reagent
BR CA27-29 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10334837
In Commercial Distribution

  • 00630414196664 ()
  • 00630414003672 ()
116735

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
BR CA27-29 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10333349
In Commercial Distribution

  • 00630414196657 ()
116734

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
Calibration Verification Material (CVM®) to verify the calibration of blood gas, electrolytes, total hemoglobin (tHb) and metabolite systems.
Siemens Healthcare Diagnostics Inc.
10316535
In Commercial Distribution

  • 00630414195131 ()
116189

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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® Conditioner kit. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers
Siemens Healthcare Diagnostics Inc.
10311078
In Commercial Distribution

  • 00630414194462 ()
  • 00630414010083 ()
478701

  • Wash/cleaning solution IVD, automated/semi-automated system
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)
No Description
Siemens Healthcare Diagnostics Inc.
10732197
In Commercial Distribution

  • 00630414194325 ()
10732197

  • Medical equipment clinical data interfacing software
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