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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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
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
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
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
Multi-Link™ DIN Converter, 3-Lead
AirLife Finland Oy
414371-001
In Commercial Distribution

414371-001

  • Electrocardiographic lead switching adaptor
Multi-Link™ DIN Converter, 12-Lead
AirLife Finland Oy
414370-012
In Commercial Distribution

414370-012

  • Electrocardiographic lead switching adaptor
Multi-Link™ DIN Converter, 5-Lead
AirLife Finland Oy
414370-001
In Commercial Distribution

414370-001

  • Electrocardiographic lead switching adaptor
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
No Description
AALTO SCIENTIFIC
K982M-5
In Commercial Distribution

  • B085K982M50 ()


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

  • B085K710M50 ()


  • 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
K026M-6
In Commercial Distribution

  • B085K026M60 ()


  • Multiple cardiac marker IVD, control
ECG adapter cable
GE Medical Systems (China) Co.,Ltd.
ECG adapter cable
In Commercial Distribution

  • 00840682147569 ()


  • Electrocardiographic lead switching adaptor
No Description
GE Healthcare Finland Oy
DIN Converter, 3-lead
In Commercial Distribution

  • 00840682140430 ()
2106403-003

  • Electrocardiographic lead switching adaptor
No Description
GE Healthcare Finland Oy
DIN Converter, 12-lead Kit
In Commercial Distribution

  • 00840682140355 ()
2106403-002

  • Electrocardiographic lead switching adaptor
No Description
GE Healthcare Finland Oy
DIN Converter, 5-lead
In Commercial Distribution

  • 00840682140157 ()
2106403-001

  • Electrocardiographic lead switching adaptor
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
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS1002
Not in Commercial Distribution

  • B103A25CS10021 ()
  • B103CS10020 ()
CS1002

  • Troponin I IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS1002
Not in Commercial Distribution

  • B103A20CS10021 ()
  • B103CS10020 ()
CS1002

  • Troponin I IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS1002
Not in Commercial Distribution

  • B103A10CS10021 ()
  • B103CS10020 ()
CS1002

  • Troponin I IVD, kit, rapid ICT, clinical
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
No Description
Response Biomedical Corp
C1101
In Commercial Distribution

  • 10627966005008 ()


  • Troponin I IVD, kit, rapid ICT, clinical
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
Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016475
In Commercial Distribution

  • 03610522248698 ()
12016475

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016474
In Commercial Distribution

  • 03610522248681 ()
12016474

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016473
In Commercial Distribution

  • 03610522248674 ()
12016473

  • Multiple cardiac marker IVD, control
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