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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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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
CRP (Wide Range) - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10313256
In Commercial Distribution

  • 00630414475714 ()
B03-4815-01

  • C-reactive protein (CRP) IVD, calibrator
CRP - ADVIA Chem. - RGT - 2x220 tests
Siemens Healthcare Diagnostics Inc.
10318309
Not in Commercial Distribution

  • 00630414475707 ()
B01-4800-01

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Special Chemistry Kit - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10311926
In Commercial Distribution

  • 00630414475677 ()
  • 00630414003450 ()
B03-4821-01

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
IBCT - ADVIA Chem. - RGT - 4x100/4x80 tests
Siemens Healthcare Diagnostics Inc.
10309071
In Commercial Distribution

  • 00630414474748 ()
3940010

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
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