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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 Size Device Size Type Device Class Implantable

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RAPIDPoint® 400/405/500 Wash/Waste Cartridge, for in vitro diagnostics use with the RAPIDPoint® 400/405/500 series systems.
Siemens Healthcare Diagnostics Inc.
10329097
In Commercial Distribution

  • 00630414482163 ()
  • 00630414009612 ()
129672

  • Wash/cleaning solution IVD, automated/semi-automated system
HAV Total - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10322682
In Commercial Distribution

  • 00630414481883 ()
5500077

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10322676
In Commercial Distribution

  • 00630414481876 ()
5498862

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
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
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
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