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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Salt Bridge Solution, 3x150mL
Siemens Healthcare Diagnostics Inc.
10444873
In Commercial Distribution

  • 00842768004735 ()
  • 00630414003788 ()
D105

  • Ion selective electrode (ISE) reference solution IVD, reagent
Stratus® CS STAT Fluorometric Analyzer Rotor is an in vitro diagnostics device which is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445088
In Commercial Distribution

  • 00842768004674 ()
  • 00630414009988 ()
CROTOR

  • Centrifuge rotor, fixed angle
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 Calibrator (MYO CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care(TM) MYO method.
Siemens Healthcare Diagnostics Inc.
10445080
In Commercial Distribution

  • 00842768004612 ()
  • 00630414009933 ()
CMYO-C

  • 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
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
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
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