Home GUDID 00856743007017 Cardiac Marker Control
Primary DI 00856743007017
Brand Cardiac Marker Control
Company MORE DIAGNOSTICS INC
Model 150
Catalog number 150
Device description 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).
Published 2018-03-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name JJT Enzyme Controls (Assayed And Unassayed)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00856743007017 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00856743007017 00856743007017 856743007017 0856743007017
GMDN Terms# Term, Definition table Term Definition Multiple cardiac marker IVD, control 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius -26 Degrees Celsius
Regulatory Flags# DUNS number 829978451 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00893038002944 Cholestech LDX™ Alere San Diego, Inc. JJT 2023-12-20 00380740156381 ARCHITECT ABBOTT LABORATORIES JJT 2020-03-03 00380740156398 ARCHITECT ABBOTT LABORATORIES JJT 2020-03-03 04015630947119 PreciControl ISD Roche Diagnostics GmbH JJT 2019-01-14 04015630947126 CalCheck ISD Roche Diagnostics GmbH JJT 2019-01-14 00380740044831 ARCHITECT ABBOTT LABORATORIES JJT 2018-07-31 00380740045593 ARCHITECT ABBOTT LABORATORIES JJT 2018-07-31 00856743007024 Cardiac Control Marker MORE DIAGNOSTICS INC JJT 2018-03-31 00856743007031 Cardiac Marker Control MORE DIAGNOSTICS INC JJT 2018-03-31 00856743007048 Cardiac Marker Control MORE DIAGNOSTICS INC JJT 2018-03-31 00893038002524 Alere Cholestech LDX® Alere San Diego, Inc. JJT 2018-03-30 M52551340 CK/LD Isoenzyme Control (5 x 2 mL) HELENA LABORATORIES CORPORATION JJT 2017-03-17 00847661001225 Liquichek BIO-RAD LABORATORIES, INC. JJT 2017-01-09 00847661001232 Liquichek BIO-RAD LABORATORIES, INC. JJT 2017-01-09 00847661002154 Liquichek BIO-RAD LABORATORIES, INC. JJT 2017-01-09 00852553007049 Enzymer Verifier Kit VERICHEM LABORATORIES, INC. JJT 2016-11-29 00852553007056 Enzymer ER Verifier Kit VERICHEM LABORATORIES, INC. JJT 2016-11-29 00852553007131 Enzymer ER Verifier, Level G VERICHEM LABORATORIES, INC. JJT 2016-11-29 00725609000205 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00725609000212 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00725609000441 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00725609000458 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00384840518902 Prodigy AutoCode Blood Glucose Monitoring System Prodigy Diabetes Care, LLC JJT 2016-09-22 00038481518505 Prodigy AutoCode Blood Glucose Monitoring System PRODIGY DIABETES CARE, LLC JJT 2016-09-22
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