Home GUDID 10627966005015 RAMP® CK-MB TEST KIT; 25 TESTS
Primary DI 10627966005015
Brand RAMP® CK-MB TEST KIT; 25 TESTS
Company Response Biomedical Corp
Model C1102
Catalog number C1102
Device description The RAMP® CK-MB test is a quantitative immunochromatographic test for the determination of CK-MB in EDTA whole blood.
Published 2016-09-05
Public version status Update
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 JHX Fluorometric Method, Cpk Or Isoenzymes
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10627966005015 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10627966005015 10627966005015
GMDN Terms# Term, Definition table Term Definition Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at 2 to 8°C (35 to 46°F). Do not freeze.
Regulatory Flags# DUNS number 248609018 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10627966005176 RAMP® Flu A + B TEST KIT; 25 TESTS C1107 C1107 2017-08-31 10627966005183 RAMP® RSV TEST KIT; 25 TESTS C1108 C1108 2017-08-31 10627966005190 RAMP® Flu A + B Control Swabs C1135 C1135 2017-08-31 10627966005206 RAMP® RSV Control Swabs C1136 C1136 2017-08-31 10627966005237 RAMP® 200 CM Control Module C2100 C2100 2017-08-31 10627966005244 RAMP® 200 TM Test Module C3100 C3100 2017-08-31 10627966005008 RAMP® Troponin I TEST KIT; 25 TESTS C1101 C1101 2016-09-05 10627966005022 RAMP® Myoglobin TEST KIT; 25 TESTS C1103 C1103 2016-09-05 10627966005046 RAMP® NT-proBNP TEST KIT; 25 TESTS C1105 C1105 2016-09-15 10627966005077 RAMP® CARDIAC CONTROLS; LEVEL 1 C2003-1 C2003-1 2017-08-31 10627966005084 RAMP® CARDIAC CONTROLS; LEVEL 2 C2003-2 C2003-2 2017-08-31 10627966005091 RAMP® CARDIAC CONTROLS; LEVEL 3 C2003-3 C2003-3 2017-08-31 10627966005220 RAMP® 1 Clinical Reader System C1100 C1100 2017-08-31 10627966005299 RAMP® Cardiac Controls - Level 1 C5003-1 C5003-1 2019-12-20 10627966005305 RAMP® Cardiac Controls - Level 2 C5003-2 C5003-2 2019-12-20
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