SEARCH RESULTS FOR: siemens(7131 results)

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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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for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.
Siemens Healthcare Diagnostics Inc.
11046781
In Commercial Distribution

  • 00630414016627 ()
11046781

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Procalcitonin (PCT) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998265
In Commercial Distribution

  • 00630414014197 ()
10998265

  • Procalcitonin (PCT) IVD, control
Dimension® EXL™ with LM Integrated Chemistry System with Reagent Management System (RMS) and Sample Transfer Module (STM)
Siemens Healthcare Diagnostics Inc.
10718149
In Commercial Distribution

  • 00630414014135 ()
759020.911

  • Multiple clinical chemistry analyser IVD, laboratory
Dimension® EXL™ with LM integrated chemistry system with Reagent Management System (RMS)
Siemens Healthcare Diagnostics Inc.
10475506
In Commercial Distribution

  • 00630414014128 ()
778020.911

  • Multiple clinical chemistry analyser IVD, laboratory
HBc IgM (aHBcM) Assay Kit - 100T
Siemens Healthcare Diagnostics Inc.
10308978
In Commercial Distribution

  • 00630414470498 ()
504619

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Digoxin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10327549
In Commercial Distribution

  • 00630414470375 ()
B01-4769-01

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
HDL/LDL Cholesterol - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10311918
In Commercial Distribution

  • 00630414470313 ()
  • 00630414003443 ()
B03-4763-01

  • Multiple lipid analyte IVD, calibrator
HER-2/NEU Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10324496
In Commercial Distribution

  • 00630414469850 ()
131217

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
TBD
Siemens Healthcare Diagnostics Inc.
10340209
In Commercial Distribution

  • 00630414469454 ()
131096

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
Siemens Healthcare Diagnostics Inc.
10329756
In Commercial Distribution

  • 00630414469225 ()
130517

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