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 - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361939
Not in Commercial Distribution

  • 00630414000190 ()
4862455

  • Myoglobin IVD, kit, nephelometry/turbidimetry
HAV IgM - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309084
In Commercial Distribution

  • 00630414480008 ()
5004800

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309083
In Commercial Distribution

  • 00630414479996 ()
5004126

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alcohol / Ammonia Kit - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10309217
In Commercial Distribution

  • 00630414479286 ()
  • 00630414003047 ()
6549444

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry for use with Clintek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10315660
In Commercial Distribution

  • 00630414479095 ()
5085

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
ISE Reference Electrode - ADVIA Chem. - CONS - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309465
In Commercial Distribution

  • 00630414478654 ()
073-0653-01

  • Reference electrode IVD
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10313971
In Commercial Distribution

  • 00630414477855 ()
130523

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10310469
In Commercial Distribution

  • 00630414477848 ()
130522

  • Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) parameters - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili. For in vitro diagnostic use with RAPIDPoint ® 405/500 systems.
Siemens Healthcare Diagnostics Inc.
10327073
In Commercial Distribution

  • 00630414477831 ()
130521

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10323175
In Commercial Distribution

  • 00630414477824 ()
130520

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
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