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 STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.
International Point of Care Incorporated
CSC3023
Not in Commercial Distribution

  • B103CSC30231 ()
  • B103CSC30230 ()
CSC3023

  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C5003-1
In Commercial Distribution

  • 10627966005299 ()
C5003-1

  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C2003-2
Not in Commercial Distribution

  • 10627966005084 ()


  • 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 3
CLINIQA CORPORATION
91492
In Commercial Distribution

  • 00817238011629 ()


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

  • 00817238011612 ()


  • Multiple cardiac marker IVD, control
Cardiac Control Complete +TnT level 1
CLINIQA CORPORATION
91490
In Commercial Distribution

  • 00817238011605 ()


  • Multiple cardiac marker IVD, control
LQC Cardiac Control CS, mini pack
CLINIQA CORPORATION
91449
In Commercial Distribution

  • 00817238011520 ()


  • Multiple cardiac marker IVD, control
LQC Cardiac Control CS, Tri-level kit
CLINIQA CORPORATION
91444
In Commercial Distribution

  • 00817238011513 ()


  • Multiple cardiac marker IVD, control
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