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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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Tacrolimus Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445012
Not in Commercial Distribution

  • 00842768004872 ()
DC107

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Aliquot Wheel Assembly - Dimension® - 8 wheels and lids
Siemens Healthcare Diagnostics Inc.
10445043
In Commercial Distribution

  • 00842768004865 ()
D830

  • Multiple clinical chemistry analyser IVD, laboratory
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 Pipette Tips are in vitro diagnostics devices which are intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445089
In Commercial Distribution

  • 00842768004681 ()
  • 00630414009995 ()
CTIP

  • Pipette tip
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
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