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 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
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065x
In Commercial Distribution

  • 00867556000171 ()


  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401db
In Commercial Distribution

  • 00859110005616 ()

  • 2 tests
401db

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401bc
In Commercial Distribution

  • 00859110005609 ()

  • 2 tests
401bc

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ab
In Commercial Distribution

  • 00859110005593 ()

  • 2 tests
401ab

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10431
In Commercial Distribution

  • 05055273217674 ()
CQ10431

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution

  • 05055273217667 ()
CQ10430

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control
This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ3259
In Commercial Distribution

  • 05055273201857 ()


  • Multiple cardiac marker IVD, control
This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ3100
In Commercial Distribution

  • 05055273201840 ()


  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
Cardiac Positive Control, 0.5 mL
MARDX DIAGNOSTICS, INC.
10-5402
In Commercial Distribution

  • 05391516747806 ()
10-5402

  • Multiple cardiac marker IVD, control
Monkey Heart 4 Well Slides, 12 each/pack
MARDX DIAGNOSTICS, INC.
10-5404
In Commercial Distribution

  • 05391516747790 ()
10-5404

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Anti Cardiac Antibody IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
10-5448
In Commercial Distribution

  • 05391516747783 ()
10-5448

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Monkey Heart 8 Well Slides, Pack of 12
MARDX DIAGNOSTICS, INC.
10-5408
In Commercial Distribution

  • 05391516747813 ()
10-5408

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ro
In Commercial Distribution

  • 00850011135228 ()

  • 2 tests
401ro

  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K982M-5
In Commercial Distribution

  • B085K982M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K936M-5
In Commercial Distribution

  • B085K936M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K935M-5
In Commercial Distribution

  • B085K935M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K908M-5
In Commercial Distribution

  • B085K908M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K906M-5
In Commercial Distribution

  • B085K906M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K891M-5
In Commercial Distribution

  • B085K891M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K887M-5
In Commercial Distribution

  • B085K887M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K804M-5
In Commercial Distribution

  • B085K804M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K710M-5
In Commercial Distribution

  • B085K710M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K026M-6
In Commercial Distribution

  • B085K026M60 ()


  • 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
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