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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 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
ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 500T
Siemens Healthcare Diagnostics Inc.
10994775
In Commercial Distribution

  • 00630414602929 ()
10994775

  • Troponin I IVD, kit, chemiluminescent immunoassay
ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10994774
In Commercial Distribution

  • 00630414602912 ()
10994774

  • Troponin I IVD, kit, chemiluminescent immunoassay
TnI-Ultra Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995697
In Commercial Distribution

  • 00630414600109 ()
10995697

  • Troponin I IVD, kit, chemiluminescent immunoassay
TnI-Ultra Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995696
In Commercial Distribution

  • 00630414600093 ()
10995696

  • Troponin I IVD, kit, chemiluminescent immunoassay
TnI-Ultra - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206219
In Commercial Distribution

  • 00630414293790 ()
11206219

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
PHC CORPORATION
N/A
In Commercial Distribution

  • 04987595301803 ()
301803

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
PHC CORPORATION
N/A
In Commercial Distribution

  • 04987595301131 ()


  • Troponin I IVD, kit, chemiluminescent immunoassay
Troponin I - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10317709
In Commercial Distribution

  • 00630414516226 ()
2790309

  • Troponin I IVD, kit, chemiluminescent immunoassay
Troponin I - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10317708
In Commercial Distribution

  • 00630414516219 ()
2789602

  • Troponin I IVD, kit, chemiluminescent immunoassay
Fibrinogen is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB30520 ()
BSB 3052

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB30510 ()
BSB 3051

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB30500 ()
BSB 3050

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB30490 ()
BSB 3049

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB30480 ()
BSB 3048

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 1 ml
In Commercial Distribution

  • B502BSB30470 ()
BSB 3047

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB300470 ()
BSB 3004-7

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2).
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB300430 ()
BSB 3004-3

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2).
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB3004150 ()
BSB 3004-15

  • Fibrinogen (Factor I) assay IVD, antibody
The Fibrinogen/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB300410 ()
BSB 3004-1

  • Fibrinogen (Factor I) assay IVD, antibody
Fibrinogen/FITC is a purified rabbit polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB3004050 ()
BSB 3004-05

  • Fibrinogen (Factor I) assay IVD, antibody
No Description
MONOBIND, INC.
3875-300
In Commercial Distribution

  • 00816870022369 ()

  • Width: 7.75 Inch
3875-300B

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
3875-300
In Commercial Distribution

  • 00816870022352 ()

  • Width: 7.75 Inch
3875-300A

  • 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 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
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