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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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 (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 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
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
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
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 Dilution Pak (ßhCG DilPak), in vitro diagnostic product intended to be used in conjunction with the Acute Care™ ßhCG TestPak on the Stratus® CS analyzer for the measurement of samples with elevated ßhCG levels.
Siemens Healthcare Diagnostics Inc.
10445062
In Commercial Distribution

  • 00842768004421 ()
  • 00630414009773 ()
CBHCG-D

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method.
Siemens Healthcare Diagnostics Inc.
10445061
In Commercial Distribution

  • 00842768004414 ()
  • 00630414009766 ()
CBHCG-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
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
Syva® Emit® Calibrator/Control Level 5
Siemens Healthcare Diagnostics Inc.
10445411
In Commercial Distribution

  • 00842768001789 ()
9A609UL

  • Multiple drugs of abuse IVD, calibrator
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