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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Cardiac Marker Control +TnI Level 2
CLINIQA CORPORATION
91482
In Commercial Distribution

  • 00817238010066 ()


  • Multiple cardiac marker IVD, control
Liquid QC Cardiac Marker Control +TnI Level 1
CLINIQA CORPORATION
91481
In Commercial Distribution

  • 00817238010059 ()


  • Multiple cardiac marker IVD, control
Cardiac Marker Control VS Tri-Levels
CLINIQA CORPORATION
91474
In Commercial Distribution

  • 00817238010042 ()


  • Multiple cardiac marker IVD, control
LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott Systems, Level D LiniCAL Cardiac CalVer for Abbott Systems, Level E
CLINIQA CORPORATION
98602
Not in Commercial Distribution

  • 00817238010028 ()


  • Multiple cardiac marker IVD, control
Cardiac Calibration Verifiers for Beckman Systems
CLINIQA CORPORATION
98232
In Commercial Distribution

  • 00817238011643 ()


  • Multiple cardiac marker IVD, control
Cardiac Calibration Verifiers for Roche Systems
CLINIQA CORPORATION
98505
In Commercial Distribution

  • 00817238011636 ()


  • Multiple cardiac marker IVD, control
Cardiac Control Complete +TnT level 2
CLINIQA CORPORATION
91491
In Commercial Distribution

  • 00817238011612 ()


  • Multiple cardiac marker IVD, control
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma
NANO-DITECH CORPORATION
TF3154
In Commercial Distribution

  • 00895160002496 ()
  • 10895160002493 ()
TF3154

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Troponin I Test
ALERE SAN DIEGO, INC.
98600EU
Not in Commercial Distribution

  • 00893038002821 ()
98600EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
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