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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Liquichek Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
146
In Commercial Distribution

  • 00847661000723 ()
146

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Marker Plus Control LT Level Low (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
149
In Commercial Distribution

  • 00847661000709 ()
149

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
648
In Commercial Distribution

  • 00847661000693 ()
648

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level 2 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
647
In Commercial Distribution

  • 00847661000686 ()
647

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
646
In Commercial Distribution

  • 00847661000679 ()
646

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Trilevel (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
645
In Commercial Distribution

  • 00847661000662 ()
645

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level Low (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
649
In Commercial Distribution

  • 00847661000655 ()
649

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
183
In Commercial Distribution

  • 00847661000648 ()
183

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
181
In Commercial Distribution

  • 00847661000624 ()
181

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control Trilevel (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
180
In Commercial Distribution

  • 00847661000617 ()
180

  • Multiple cardiac marker IVD, control
PBM Cardiac Marker Control Set (2 x 1 mL)
PRINCETON BIOMEDITECH CORPORATION
LSC-300C-01
In Commercial Distribution

  • 10743816001607 ()
LSC-300C-01

  • Multiple cardiac marker IVD, control
PBM Cardiac Marker Control Set (2 x 1 mL)
PRINCETON BIOMEDITECH CORPORATION
LSC-301
In Commercial Distribution

  • 10743816001355 ()
LSC-301

  • Multiple cardiac marker IVD, control
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
CARDIAC MARKER CONTROL TRI-LEVEL
CLINIQA CORPORATION
91484
In Commercial Distribution

  • 00817238010080 ()


  • Multiple cardiac marker IVD, control
CARDIAC MARKER CONTROL +TnI Level 3
CLINIQA CORPORATION
91483
In Commercial Distribution

  • 00817238010073 ()


  • Multiple cardiac marker IVD, control
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 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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