Home GUDID 00895160002021 Nano-CheckTM AMI CK-MB
Primary DI 00895160002021
Brand Nano-CheckTM AMI CK-MB
Company NANO-DITECH CORPORATION
Model CD7142
Catalog number CD7142
Device description In Vitro Diagnostic Test kit for the detection of Creatine kinase MB in human whole blood, serum and plasma
Published 2016-10-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name JHT Chromatographic Separation, Cpk Isoenzymes
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHT Chromatographic Separation, Cpk Isoenzymes Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00895160002021 Primary GS1 0 10895160002028 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00895160002021 00895160002021 895160002021 0895160002021 10895160002028 10895160002028
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 126544316 Device count 20 Kit true 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 00895160002496 Fluoro-CheckTM AMI 3 in 1 NANO-DITECH CORPORATION JHT 2019-05-24 00895160002458 Nano-CheckTM 4 in 1 Test NANO-DITECH CORPORATION JHT 2016-10-03 10743816001324 LifeSign® MI CK-MB/Myo/TnI card PRINCETON BIOMEDITECH CORPORATION JHT 2016-09-23 10743816001331 LifeSign® MI StatusFirst CK-MB/Myo/TnI card PRINCETON BIOMEDITECH CORPORATION JHT 2016-09-23 10743816001348 LifeSign® MI StatusFirst CK-MB/Myo/TnI card PRINCETON BIOMEDITECH CORPORATION JHT 2016-09-23 B103A10CS30021 Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test International Point of Care Incorporated JHT 2016-09-15 B103A20CS30021 Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test International Point of Care Incorporated JHT 2016-09-15 B103A25CS30021 Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test International Point of Care Incorporated JHT 2016-09-15 00895160002090 Nano-CheckTM AMI 3 in 1 NANO-DITECH CORPORATION JHT 2016-09-14 00895160002137 Nano-CheckTM AMI 3 in 1 NANO-DITECH CORPORATION JHT 2016-09-14
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