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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 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 UniCel DxI Immunoassay System to aid in the diagnosis of myocardial infarction.
Beckman Coulter, Inc.
A98264
In Commercial Distribution

  • 15099590209353 ()
A98264

  • Troponin I IVD, kit, chemiluminescent immunoassay
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
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
No Description
Ventana Medical Systems, Inc.
05267960001
In Commercial Distribution

  • 04015630971442 ()
05267960001

  • Fibrinogen (Factor I) assay IVD, antibody
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802301
In Commercial Distribution

  • 10758750002504 ()
  • 20758750002501 ()
6802301

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
3825-300
In Commercial Distribution

  • 00816870020686 ()

  • Width: 7.75 Inch
3825-300B

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
3825-300
In Commercial Distribution

  • 00816870020679 ()

  • Width: 7.75 Inch
3825-300A

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
A test for the quantitative measure of cross-linked N-telopeptides of Type I Collagen (NTx) in human serum as an indicator of bone resorption.
Alere Scarborough, Inc.
9021
Not in Commercial Distribution

  • 10811877010941 ()


  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (EIA) for the measurement of cross-linked N-telopeptides of Type I Collagen (NTx) in human urine.
Alere Scarborough, Inc.
9006
Not in Commercial Distribution

  • 10811877010934 ()


  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
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