Home GUDID 06438147362615 GSP Neonatal Creatine Kinase -MM kit
Primary DI 06438147362615
Brand GSP Neonatal Creatine Kinase -MM kit
Company Wallac Oy
Model 3311-001U
Catalog number 3311-001U
Device description For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood.Note: Kit contains multiple packages.
Published 2021-06-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QJE Muscular Dystrophy Newborn Screening Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QJE Muscular Dystrophy Newborn Screening Test Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06438147362615 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06438147362615 06438147362615 6438147362615
GMDN Terms# Term, Definition table Term Definition Creatine kinase skeletal muscle isoenzyme (CKMM) IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase skeletal muscle isoenzyme (CKMM) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to assess the extent of muscle damage in and to screen for muscular dystrophy.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -30 Degrees Celsius -16 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 540156544 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company#