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™ NT-proBNP Dilution Pak (pBNP DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ pBNP TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP.
Siemens Healthcare Diagnostics Inc.
10445085
In Commercial Distribution

  • 00842768004667 ()
  • 00630414009957 ()
CPBNP-D

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care(TM) Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) MYO TestPak for the measurement of samples with elevated levels of Myoglobin.
Siemens Healthcare Diagnostics Inc.
10445081
In Commercial Distribution

  • 00842768004629 ()
  • 00630414009940 ()
CMYO-D

  • Myoglobin IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care(TM) Myoglobin (MYO) method is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445079
In Commercial Distribution

  • 00842768004605 ()
  • 00630414009926 ()
CMYO

  • Myoglobin IVD, kit, fluorescent immunoassay
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™ 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
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
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