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
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
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
No Description
Microgenics Corporation
OCRD-SP
In Commercial Distribution

  • 00884883011991 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-202
In Commercial Distribution

  • 00884883011977 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-L
In Commercial Distribution

  • 00884883011953 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-UL
In Commercial Distribution

  • 00884883011946 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-MP
In Commercial Distribution

  • 00884883012004 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-303
In Commercial Distribution

  • 00884883011984 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-101
In Commercial Distribution

  • 00884883011960 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014182
In Commercial Distribution

  • 00884883004399 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014181
In Commercial Distribution

  • 00884883004382 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014180
In Commercial Distribution

  • 00884883004375 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014179
In Commercial Distribution

  • 00884883004368 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XLS
In Commercial Distribution

  • 00884883003613 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL4
In Commercial Distribution

  • 00884883003606 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XLL
In Commercial Distribution

  • 00884883002371 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL3
In Commercial Distribution

  • 00884883002364 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL2
In Commercial Distribution

  • 00884883002357 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL1
In Commercial Distribution

  • 00884883002340 ()


  • Multiple cardiac marker IVD, control
Alere Triage® Troponin I Test
ALERE SAN DIEGO, INC.
98600EU
Not in Commercial Distribution

  • 00893038002821 ()
98600EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio3 Panel
ALERE SAN DIEGO, INC.
97400EU
Not in Commercial Distribution

  • 00893038002807 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
VITROS Chemistry Products Isoenzyme Performance Verifier II
ORTHO-CLINICAL DIAGNOSTICS, INC.
8748220
In Commercial Distribution

  • 10758750005154 ()
8748220

  • Multiple cardiac marker IVD, control
VITROS Chemistry Products Isoenzyme Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
8721508
In Commercial Distribution

  • 10758750005123 ()
8721508

  • 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
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
Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016472
In Commercial Distribution

  • 03610522248667 ()
12016472

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016450
In Commercial Distribution

  • 03610522248407 ()
12016450

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016449
In Commercial Distribution

  • 03610522248391 ()
12016449

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016448
In Commercial Distribution

  • 03610522248384 ()

  • 6 x 3 ml
12016448

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016447
In Commercial Distribution

  • 03610522248377 ()
12016447

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009966
In Commercial Distribution

  • 03610522114436 ()
12009966

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009965
In Commercial Distribution

  • 03610522114429 ()
12009965

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009964
In Commercial Distribution

  • 03610522114412 ()
12009964

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009963
In Commercial Distribution

  • 03610522114405 ()
12009963

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009962
In Commercial Distribution

  • 03610522114399 ()
12009962

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009961
In Commercial Distribution

  • 03610522114382 ()
12009961

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009960
In Commercial Distribution

  • 03610522114375 ()
12009960

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009959
In Commercial Distribution

  • 03610522114368 ()
12009959

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009958
In Commercial Distribution

  • 03610522114351 ()
12009958

  • Multiple cardiac marker IVD, control
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