FDA.reportPublic FDA data

Multiple cardiac marker IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.
GUDID devices
151
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03610522248377LiquichekBIO-RAD LABORATORIES, INC.120164472023-01-31
03610522248384LiquichekBIO-RAD LABORATORIES, INC.120164482023-01-31
03610522248391LiquichekBIO-RAD LABORATORIES, INC.120164492023-01-31
03610522248407LiquichekBIO-RAD LABORATORIES, INC.120164502023-01-31
03610522248667LiquichekBIO-RAD LABORATORIES, INC.120164722023-01-31
03610522248674LiquichekBIO-RAD LABORATORIES, INC.120164732023-01-31
03610522248681LiquichekBIO-RAD LABORATORIES, INC.120164742023-01-31
03610522248698LiquichekBIO-RAD LABORATORIES, INC.120164752023-01-31
03610522248872InteliQBIO-RAD LABORATORIES, INC.120164842023-01-31
03610522248889InteliQBIO-RAD LABORATORIES, INC.120164852023-01-31
03610522248896InteliQBIO-RAD LABORATORIES, INC.120164862023-01-31
03610522248902InteliQBIO-RAD LABORATORIES, INC.120164872023-01-31
10627966005299RAMP® Cardiac Controls - Level 1Response Biomedical CorpC5003-12019-12-20
10627966005305RAMP® Cardiac Controls - Level 2Response Biomedical CorpC5003-22019-12-20
10743816001355PBM Cardiac Marker ControlPRINCETON BIOMEDITECH CORPORATIONLSC-3012016-09-23
B085K908M50Audit MicroControls Linearity FLQ Cardiac Markers for Ortho VitrosAALTO SCIENTIFICK908M-52023-06-15
B085K936M50Audit MicroControls Linearity FLQ Cardiac Markers for Roche SystemsAALTO SCIENTIFICK936M-52023-06-15
B103CSC30231Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)International Point of Care IncorporatedCSC30232022-12-07
00817238011520LQC Cardiac Control CS, mini packCLINIQA CORPORATION914492022-11-19
05055273201840TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3)RANDOX LABORATORIES LIMITEDCQ31002022-10-04
05055273201857TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3)RANDOX LABORATORIES LIMITEDCQ32592022-10-04
05055273217346CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low)RANDOX LABORATORIES LIMITEDCQ104282022-09-22
05055273217650CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1)RANDOX LABORATORIES LIMITEDCQ104292022-09-22
05055273217667CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2)RANDOX LABORATORIES LIMITEDCQ104302022-09-22
05055273217674CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3)RANDOX LABORATORIES LIMITEDCQ104312022-09-22
10743816001607PBM Cardiac Marker ControlPRINCETON BIOMEDITECH CORPORATIONLSC-300C-012022-03-29
00850011135228ValidateLgc Clinical Diagnostics, Inc.401ro2020-10-05
B085K982M50Audit MicroControls Linearity FD Cardiac Markers for PATHFAST ImmunoanalyzerAALTO SCIENTIFICK982M-52022-02-04
B085K906M50Audit MicroControls Linearity FD Cardiac Markers for Ortho VitrosAALTO SCIENTIFICK906M-52021-07-23
B085K935M50Audit MicroControls Linearity FD Cardiac Markers for Roche SystemsAALTO SCIENTIFICK935M-52021-07-07
04015630939138PreciControl Cardiac IIRoche Diagnostics GmbH49170491602021-01-18
03610520865217LiquichekBIO-RAD LABORATORIES, INC.120048062020-09-14
03610520865224LiquichekBIO-RAD LABORATORIES, INC.120048072020-09-14
03610520865231LiquichekBIO-RAD LABORATORIES, INC.120048082020-09-14
03610520865248LiquichekBIO-RAD LABORATORIES, INC.120048092020-09-14
03610520865255LiquichekBIO-RAD LABORATORIES, INC.120048102020-09-14
03610520865262LiquichekBIO-RAD LABORATORIES, INC.120048112020-09-14
03610520865279LiquichekBIO-RAD LABORATORIES, INC.120048122020-09-14
03610520865286LiquichekBIO-RAD LABORATORIES, INC.120048132020-09-14
03610520865293LiquichekBIO-RAD LABORATORIES, INC.120048142020-09-14
03610520865309LiquichekBIO-RAD LABORATORIES, INC.120048152020-09-14
03610520865316LiquichekBIO-RAD LABORATORIES, INC.120048162020-09-14
03610520865323LiquichekBIO-RAD LABORATORIES, INC.120048172020-09-14
03610521174905LiquichekBIO-RAD LABORATORIES, INC.120062392020-09-14
03610521174929LiquichekBIO-RAD LABORATORIES, INC.120063692020-09-14
03610521174936LiquichekBIO-RAD LABORATORIES, INC.120063702020-09-14
03610521174943LiquichekBIO-RAD LABORATORIES, INC.120063712020-09-14
03610522114320InteliQBIO-RAD LABORATORIES, INC.120099552020-09-02
03610522114337InteliQBIO-RAD LABORATORIES, INC.120099562020-09-02
03610522114344InteliQBIO-RAD LABORATORIES, INC.120099572020-09-02
03610522114351InteliQBIO-RAD LABORATORIES, INC.120099582020-09-02
03610522114368InteliQBIO-RAD LABORATORIES, INC.120099592020-09-02
03610522114375InteliQBIO-RAD LABORATORIES, INC.120099602020-09-02
03610522114382InteliQBIO-RAD LABORATORIES, INC.120099612020-09-02
03610522114399InteliQBIO-RAD LABORATORIES, INC.120099622020-09-02
03610522114405InteliQBIO-RAD LABORATORIES, INC.120099632020-09-02
03610522114412InteliQBIO-RAD LABORATORIES, INC.120099642020-09-02
03610522114429InteliQBIO-RAD LABORATORIES, INC.120099652020-09-02
03610522114436InteliQBIO-RAD LABORATORIES, INC.120099662020-09-02
00817238010028Cardiac CalVer for Abbott Systems, Level A-ECLINIQA CORPORATION986022020-07-31
10758750005123VITROSORTHO-CLINICAL DIAGNOSTICS, INC.87215082020-04-18
10758750005154VITROSORTHO-CLINICAL DIAGNOSTICS, INC.87482202020-04-18
00850011135204ValidateLgc Clinical Diagnostics, Inc.409ro2020-03-09
00859110005609ValidateLgc Clinical Diagnostics, Inc.401bc2020-03-02
00859110005616ValidateLgc Clinical Diagnostics, Inc.401db2020-03-02
00859110005593ValidateLgc Clinical Diagnostics, Inc.401ab2020-02-15
00817238011636Cardiac Calibration Verifiers for Roche Systems CLINIQA CORPORATION985052020-01-31
00817238011643Cardiac Calibration Verifiers for Beckman Systems CLINIQA CORPORATION982322020-01-31
03610520551356LiquichekBIO-RAD LABORATORIES, INC.120010842017-01-09
03610520551707LiquichekBIO-RAD LABORATORIES, INC.120010852017-01-09
10627966005077RAMP® CARDIAC CONTROLS; LEVEL 1 Response Biomedical CorpC2003-12017-08-31
10627966005084RAMP® CARDIAC CONTROLS; LEVEL 2Response Biomedical CorpC2003-22017-08-31
10627966005091RAMP® CARDIAC CONTROLS; LEVEL 3Response Biomedical CorpC2003-32017-08-31
30014613337041TriageQUIDEL CARDIOVASCULAR INC.98713EU2018-11-07
30014613337058TriageQUIDEL CARDIOVASCULAR INC.98714EU2018-11-07
30014613337089TriageQUIDEL CARDIOVASCULAR INC.887332018-11-01
30014613337096TriageQUIDEL CARDIOVASCULAR INC.887342018-11-01
30014613337102TriageQUIDEL CARDIOVASCULAR INC.887532018-11-01
30014613337119TriageQUIDEL CARDIOVASCULAR INC.887542018-11-01
30014613337126TriageQUIDEL CARDIOVASCULAR INC.887552018-11-01