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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CA 15-3 - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10329796
In Commercial Distribution

  • 00630414461359 ()
128538

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
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
RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution
Siemens Healthcare Diagnostics Inc.
10318630
In Commercial Distribution

  • 00630414452319 ()
3279837

  • Multiple blood gas analyte IVD, calibrator
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
Valve module an in vitro diagnostics device to be used on the RAPIDChem® 744/754 analyzer
Siemens Healthcare Diagnostics Inc.
10309056
In Commercial Distribution

  • 00630414452142 ()
3372381

  • Blood gas/haemoximetry analyser IVD, point-of-care
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)
RAPIDChem® 700 Urine Diluent for in vitro use with Rapidchem® 700 systems. Contains: buffers & presevatives
Siemens Healthcare Diagnostics Inc.
10308995
In Commercial Distribution

  • 00630414452104 ()
938058

  • Buffered sample diluent IVD
RAPIDChem® 744 Daily Cleaner Kit, for in vitro diagnostics use with Rapidchem® 744 systems.
Siemens Healthcare Diagnostics Inc.
10309011
In Commercial Distribution

  • 00630414452098 ()
1331777

  • Wash/cleaning solution IVD, automated/semi-automated system
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