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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 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™ 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™ 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
Syva® Emit® Ethyl Alcohol High Control
Siemens Healthcare Diagnostics Inc.
10445449
In Commercial Distribution

  • 00842768002007 ()
9K079UL

  • Ethanol (ETOH) IVD, control
Syva® Emit® Ethyl Alcohol Low Control
Siemens Healthcare Diagnostics Inc.
10445447
In Commercial Distribution

  • 00842768001987 ()
9K049UL

  • Ethanol (ETOH) IVD, control
Syva® Emit® tox Salicylic Acid Calibrators
Siemens Healthcare Diagnostics Inc.
10445393
In Commercial Distribution

  • 00842768001628 ()
7S109UL

  • Salicylate IVD, calibrator
Syva® Emit® tox Serum Barbiturate Assay
Siemens Healthcare Diagnostics Inc.
10445391
In Commercial Distribution

  • 00842768001604 ()
7D119UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Serum Calibrators
Siemens Healthcare Diagnostics Inc.
10445387
In Commercial Distribution

  • 00842768001574 ()
7B019UL

  • Multiple drugs of abuse IVD, calibrator
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