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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 Class Implantable

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Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry - 00630414479095

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

ADVIA® Chemistry Systems Reference Electrode - 00630414478654

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 - 00630414477855

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 - 00630414477848

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 - 00630414477831

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 - 00630414477824

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

ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators - 00630414475714

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

ADVIA® Chemistry wr CRP Wide Range C-Reactive Protein Reagents - 00630414475707

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

ADVIA® Chemistry Special Chemistry Calibrator - 00630414475677

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

ADVIA® Chemistry LAC Lactate Reagents - 00630414475660

Lactate - ADVIA Chem. - RGT - 3x100 tests
Siemens Healthcare Diagnostics Inc.
10325776
In Commercial Distribution

  • 00630414475660 ()
  • 00630414003580 ()
B01-4818-01

  • Lactate IVD, kit, spectrophotometry
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