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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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Stratus® CS STAT Fluorometric Analyzer Waste Container holds used rotors, tips, cups and paks and is an in vitro diagnostic product intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445078
In Commercial Distribution

  • 00842768004599 ()
  • 00630414009919 ()
CLINER

  • Contaminated waste container
The Stratus® CS Acute Care(TM) D-dimer Dilution Pak (DDMR DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) DDMR TestPak for the measurement of samples with elevated levels of D-dimer.
Siemens Healthcare Diagnostics Inc.
10445077
In Commercial Distribution

  • 00842768004582 ()
  • 00630414009902 ()
CDDMR-D

  • D-dimer IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ DDMR Calibrator (DDMR CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ DDMR method
Siemens Healthcare Diagnostics Inc.
10445076
In Commercial Distribution

  • 00842768004575 ()
  • 00630414009896 ()
CDDMR-C

  • D-dimer IVD, kit, fluorescent immunoassay
Stratus® CS STAT Fluorometric Analyzer sample cups are used to introduce quality control (QC) material or previously centrifuged plasma for processing.
Siemens Healthcare Diagnostics Inc.
10445074
In Commercial Distribution

  • 00842768004551 ()
  • 00630414009889 ()
CCUPS

  • General laboratory container, single-use
The Stratus® CS Acute Care™ Cardiac Troponin I Dilution Pak (cTNI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTNI TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of cardiac Troponin I.
Siemens Healthcare Diagnostics Inc.
10445073
In Commercial Distribution

  • 00842768004544 ()
  • 00630414009872 ()
CCTNI-D

  • Troponin I IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ Troponin I Calibrator (cTNI CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ cTNI method.
Siemens Healthcare Diagnostics Inc.
10445072
In Commercial Distribution

  • 00842768004537 ()
  • 00630414009865 ()
CCTNI-CR

  • Troponin I IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ CKMB Dilution Pak (CKMB DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CKMB TestPak on the Stratus® CS analyzer for the measurement of samples with elevated CKMB levels.
Siemens Healthcare Diagnostics Inc.
10445070
In Commercial Distribution

  • 00842768004513 ()
  • 00630414009841 ()
CCKMB-D

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care (TM) CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care (TM) CKMB method.
Siemens Healthcare Diagnostics Inc.
10445069
In Commercial Distribution

  • 00842768004506 ()
  • 00630414009834 ()
CCKMB-C

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein Calibrator (CCRP CalPak) is an in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445067
In Commercial Distribution

  • 00842768004476 ()
  • 00630414009810 ()
CCCRP-C

  • C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager.
Siemens Healthcare Diagnostics Inc.
10445064
In Commercial Distribution

  • 00842768004445 ()
  • 00630414009797 ()
CCANS

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
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