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 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 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 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 Trilevel (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
180
In Commercial Distribution

  • 00847661000617 ()
180

  • Multiple cardiac marker IVD, control
Liquichek CK/LD Isoenzyme Control Level MiniPak (A human serum assayed CK/LD isoenzyme control.)
BIO-RAD LABORATORIES, INC.
670X
In Commercial Distribution

  • 00847661002154 ()
670X

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

  • 00847661002123 ()
649X

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

  • 00847661001911 ()
645X

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

  • 00847661001744 ()
180X

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

  • 00847661001737 ()
149X

  • Multiple cardiac marker IVD, control
Liquichek CK/LD Isoenzyme Control Level 2 (A human serum assayed CK/LD isoenzyme control.)
BIO-RAD LABORATORIES, INC.
672
In Commercial Distribution

  • 00847661001232 ()
672

  • Multiple cardiac marker IVD, control
Liquichek CK/LD Isoenzyme Control Level 1 (A human serum assayed CK/LD isoenzyme control.)
BIO-RAD LABORATORIES, INC.
671
In Commercial Distribution

  • 00847661001225 ()
671

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
147
In Commercial Distribution

  • 00847661000730 ()
147

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

  • 00867556000171 ()


  • 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
InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016485
In Commercial Distribution

  • 03610522248889 ()
12016485

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016484
In Commercial Distribution

  • 03610522248872 ()
12016484

  • Multiple cardiac marker IVD, control
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