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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Alpha-Fetoprotein (AFP) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10311625
In Commercial Distribution

  • 00630414126319 ()
672428000

  • Alpha-fetoprotein (AFP) IVD, control
CEA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311624
In Commercial Distribution

  • 00630414126302 ()
672427000

  • Carcinoembryonic antigen (CEA) IVD, control
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
Xprecia™ System PT/INR Strips, is intended for use by professional healthcare providers to provide an INR (International NormalizedRatio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin
Siemens Healthcare Diagnostics Inc.
11065645
In Commercial Distribution

  • 00630414034348 ()
  • 00630414188690 ()
11065645

  • Prothrombin time (PT) IVD, reagent
Emit II Plus Specialty Multi Drug Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10720807
In Commercial Distribution

  • 00630414028026 ()
9T529UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Oxycodone Negative Control 100
Siemens Healthcare Diagnostics Inc.
10720809
In Commercial Distribution

  • 00630414028002 ()
9T609UL

  • Oxycodone IVD, control
Emit II Plus Oxycodone Negative Control 300
Siemens Healthcare Diagnostics Inc.
10720811
In Commercial Distribution

  • 00630414027982 ()
9T709UL

  • Oxycodone IVD, control
Emit II Plus Specialty Multi Drug Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10720813
In Commercial Distribution

  • 00630414027968 ()
9T549UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Specialty Multi Drug Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10720815
In Commercial Distribution

  • 00630414027944 ()
9T589UL

  • Multiple drugs of abuse IVD, calibrator
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