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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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High-Sensitivity Troponin (TNIH) Dimension Vista - RGT 120T
Siemens Healthcare Diagnostics Inc.
10471067
In Commercial Distribution

  • 00842768037719 ()
  • 00630414225197 ()
K6427

  • Troponin I IVD, kit, chemiluminescent 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™ 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
Rabbit Anti-Human Fibrinogen FIT- Conjugated 1 ml
Slmp, LLC
Rabbit Anti-Human Fibrinogen FIT- Conjugated 1 ml
In Commercial Distribution

  • 00810170550102 ()
FITC-006-01

  • Fibrinogen (Factor I) assay IVD, antibody
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
The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent 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.
Beckman Coulter, Inc.
A98265
In Commercial Distribution

  • 15099590209360 ()
A98265

  • 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 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
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
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
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211032 ()


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

  • 00630414180380 ()
  • 00630414225227 ()
RC627

  • Troponin I IVD, calibrator
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
ZEUS SCIENTIFIC, INC.
XJ9021
In Commercial Distribution

  • 00845533002004 ()
XJ9021

  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
ZEUS SCIENTIFIC, INC.
NTx9021
In Commercial Distribution

  • 00845533001953 ()
XJ9021

  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human urine.
ZEUS SCIENTIFIC, INC.
NTx9006
In Commercial Distribution

  • 00845533001878 ()


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