Home GUDID 00856743007031 Cardiac Marker Control
Primary DI 00856743007031
Brand Cardiac Marker Control
Company MORE DIAGNOSTICS INC
Model 150-2
Catalog number 150-2
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 2018-03-31
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 00856743007031 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 00856743007031 00856743007031 856743007031 0856743007031
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 00856743007048 Cardiac Marker Control MORE DIAGNOSTICS INC JJT 2018-03-31 00893038002524 Alere Cholestech LDX® Alere San Diego, Inc. JJT 2018-03-30 00856743007017 Cardiac Marker Control MORE DIAGNOSTICS 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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