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 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
CARDIAC MARKER CONTROL TRI-LVL (min-pack)
CLINIQA CORPORATION
91489
Not in Commercial Distribution

  • 00817238010097 ()


  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C5003-2
In Commercial Distribution

  • 10627966005305 ()
C5003-2

  • 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
C2003-3
Not in Commercial Distribution

  • 10627966005091 ()


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

  • 10627966005084 ()


  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C2003-1
Not in Commercial Distribution

  • 10627966005077 ()


  • Multiple cardiac marker IVD, control
Triage Cardio2 Panel
QUIDEL CARDIOVASCULAR INC.
97500EU
In Commercial Distribution

  • 30014613337973 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardio3 Panel
QUIDEL CARDIOVASCULAR INC.
97400EU
In Commercial Distribution

  • 30014613337966 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Profiler SOB Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97300EU
In Commercial Distribution

  • 30014613337959 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (CK/TnI)
QUIDEL CARDIOVASCULAR INC.
97022HS
In Commercial Distribution

  • 30014613337942 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97000HSEU
In Commercial Distribution

  • 30014613337928 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel
QUIDEL CARDIOVASCULAR INC.
97000HS
In Commercial Distribution

  • 30014613337911 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Quidel Triage Total 5 Calibration Verification
QUIDEL CARDIOVASCULAR INC.
88755
In Commercial Distribution

  • 30014613337126 ()
88755

  • Multiple cardiac marker IVD, control
Quidel Triage Total 5 Control 2
QUIDEL CARDIOVASCULAR INC.
88754
In Commercial Distribution

  • 30014613337119 ()
88754

  • Multiple cardiac marker IVD, control
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