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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LH 2 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309794
In Commercial Distribution

  • 00630414057361 ()
106794

  • Luteinizing hormone (LH) IVD, control
Ready Sensor™ Hct Biosensor for in vitro use on the RapidLab® 348/348ex pH/Blood Gas Analyzers.
Siemens Healthcare Diagnostics Inc.
10309783
In Commercial Distribution

  • 00630414056296 ()
106042

  • Multiple blood gas analyte IVD, calibrator
CK-MB 2 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309782
In Commercial Distribution

  • 00630414056098 ()
105805

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, control
RAPIDLab® 348/348EX HCT Slope for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.
Siemens Healthcare Diagnostics Inc.
10309776
In Commercial Distribution

  • 00630414055930 ()
  • 00630414010045 ()
105670

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
RAPIDLab® Deproteinizer for in vitro diagnostics use with the RAPIDLab® series analyzers (Pack 10)
Siemens Healthcare Diagnostics Inc.
10309775
In Commercial Distribution

  • 00630414055909 ()
  • 00630414010038 ()
105610

  • Wash/cleaning solution IVD, automated/semi-automated system
For in vitro diagnostics use for calibration of the RapidLab® 348/348ex pH/Blood Gas Analyzers
Siemens Healthcare Diagnostics Inc.
10309768
In Commercial Distribution

  • 00630414055657 ()
105070

  • Multiple blood gas analyte IVD, calibrator
Vitamin B12 - Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309760
In Commercial Distribution

  • 00630414054124 ()
104523

  • Vitamin B12 IVD, control
RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent
Siemens Healthcare Diagnostics Inc.
10309757
In Commercial Distribution

  • 00630414053455 ()
104227

  • Multiple blood gas analyte IVD, calibrator
RAPIDLab® 348/348EX Wash Reagent for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.
Siemens Healthcare Diagnostics Inc.
10309756
In Commercial Distribution

  • 00630414053448 ()
  • 00630414010021 ()
104226

  • Wash/cleaning solution IVD, automated/semi-automated system
Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Lactate Warranty Replacement
Siemens Healthcare Diagnostics Inc.
10334138
In Commercial Distribution

  • 00630414051499 ()
102455

  • Lactate electrode IVD
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