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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™ 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™ Troponin I method (cTNI) is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445071
In Commercial Distribution

  • 00842768004520 ()
  • 00630414009858 ()
CCTNI

  • Troponin I IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care (TM) CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E. C. No. 2.7.3.2) in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445068
In Commercial Distribution

  • 00842768004490 ()
  • 00630414009827 ()
CCKMB

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP method (hsCRP) is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma and is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445066
In Commercial Distribution

  • 00842768004469 ()
  • 00630414009803 ()
CCCRP

  • C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer.
Siemens Healthcare Diagnostics Inc.
10445063
In Commercial Distribution

  • 00842768004438 ()
  • 00630414009780 ()
CCANBD

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution

  • 00842768004407 ()
  • 00630414009759 ()
CBHCG

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
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