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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CA125 - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10310444
In Commercial Distribution

  • 00630414461335 ()
128536

  • Cancer antigen 125 (CA125) IVD, calibrator
CA 15-3 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10312831
In Commercial Distribution

  • 00630414461328 ()
  • 00630414003481 ()
128535

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 15-3 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10327620
In Commercial Distribution

  • 00630414461311 ()
128534

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Testosterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322623
Not in Commercial Distribution

  • 00630414454658 ()
  • 00630414010519 ()
125363

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Folic Acid (Ref) - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10331250
In Commercial Distribution

  • 00630414454597 ()
126638

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems.
Siemens Healthcare Diagnostics Inc.
10309082
In Commercial Distribution

  • 00630414452289 ()
4955798

  • Potassium (K+) electrode IVD
Cl- Sensor module an in vitro diagnostics device to be used on the RAPIDChem® 744 analyzer
Siemens Healthcare Diagnostics Inc.
10309086
In Commercial Distribution

  • 00630414452135 ()
5453710

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems.
Siemens Healthcare Diagnostics Inc.
10317312
In Commercial Distribution

  • 00630414452074 ()
2577729

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems
Siemens Healthcare Diagnostics Inc.
10308981
In Commercial Distribution

  • 00630414451862 ()
583772

  • Lithium electrode IVD
RAPIDChem® 700 RAPIDPoint® 350 Na+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint® 350 systems.
Siemens Healthcare Diagnostics Inc.
10309075
In Commercial Distribution

  • 00630414451848 ()
4473866

  • Sodium (Na+) electrode IVD
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