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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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The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 System to aid in the diagnosis of myocardial infarction.
Beckman Coulter, Inc.
A98144
In Commercial Distribution

  • 15099590209339 ()
A98144

  • Troponin I IVD, kit, chemiluminescent immunoassay
The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
Beckman Coulter, Inc.
A98143
In Commercial Distribution

  • 15099590209322 ()
A98143

  • Troponin I IVD, kit, chemiluminescent immunoassay
Triage Troponin I Test (OUS)
QUIDEL CARDIOVASCULAR INC.
98600EU
In Commercial Distribution

  • 30014613338024 ()
98600EU

  • Troponin I IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (TnI)
QUIDEL CARDIOVASCULAR INC.
97021HS
In Commercial Distribution

  • 30014613337935 ()
97021HS

  • Troponin I IVD, kit, fluorescent immunoassay
The Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay for quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
C26909
In Commercial Distribution

  • 15099590707194 ()
C26909

  • Troponin I IVD, kit, chemiluminescent immunoassay
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).
Beckman Coulter, Inc.
B52669
In Commercial Distribution

  • 15099590693183 ()
B52699

  • Troponin I IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802301
In Commercial Distribution

  • 10758750002504 ()
  • 20758750002501 ()
6802301

  • Troponin I IVD, kit, chemiluminescent immunoassay
LOCI High-Sensitivity Troponin Calibrator
Siemens Healthcare Diagnostics Inc.
10719483
In Commercial Distribution

  • 00630414180380 ()
  • 00630414225227 ()
RC627

  • Troponin I IVD, calibrator
High-Sensitvity Troponin Calibrator Dimension Vista - CAL 5 Levels 2 VL/Level
Siemens Healthcare Diagnostics Inc.
10719482
In Commercial Distribution

  • 00630414180373 ()
  • 00630414225210 ()
KC627

  • Troponin I IVD, calibrator
i-STAT hs-TnI cartridge
Abbott Point of Care Inc.
09P81-25
In Commercial Distribution

  • 00054749003051 ()
  • 10054749003058 ()
09P81-25

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
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