Home GUDID 06438147348107 NeoBase 2 Non-derivatized Assay Solutions
Primary DI 06438147348107
Brand NeoBase 2 Non-derivatized Assay Solutions
Company Wallac Oy
Model 3045-0010
Catalog number 3045-0010
Device description NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system.
Published 2019-02-25
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 NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06438147348107 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06438147348107 06438147348107 6438147348107
GMDN Terms# Term, Definition table Term Definition Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple amino acids, nucleosides, lysophospholipids, and/or carnitine metabolites associated with metabolic disorders of a newborn in a clinical specimen, using a mass spectrometry method. Analytes detected may include all amino acids, free carnitine, acylcarnitine, succinylacetone, adenosine and/or lysophosphatidylcholine.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from heat and sunlight Special Storage Condition, Specify 0 0 Store in the dark Storage Environment Temperature 2 Degrees Celsius 30 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06438147356812 NeoBase 2 Non-derivatized MSMS kit Wallac Oy NQL 2019-02-25 06438147356829 NeoBase 2 Succinylacetone Assay Solution Wallac Oy NQL 2019-02-25 06438147283842 NeoGram Derivatized Assay Solutions Wallac Oy NQL 2016-02-11 06438147295692 NeoBase Non-derivatized Assay Solutions Wallac Oy NQL 2016-02-11 06438147295708 NeoBase Succinylacetone Assay Solution Wallac Oy NQL 2016-02-11 06438147283835 NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit Wallac Oy NQL 2016-01-12 06438147311859 NeoBase Non-derivatized MSMS kit Wallac Oy NQL 2016-01-12