NeoBase Non-derivatized Assay Solutions

Primary DI
06438147295692
Brand
NeoBase Non-derivatized Assay Solutions
Company
Wallac Oy
Model
3041-0020
Catalog number
3041-0020
Device description
This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper.This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution.
Published
2016-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass SpectrometryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083130000
K093916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083130000NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040Perkinelmer, Inc.2009-07-09NQL
K093916000NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001UPerkinelmer, Inc.2010-08-23NQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147295692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147295692064381472956926438147295692

GMDN Terms#

Term, Definition table
TermDefinition
Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometryA 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06438147348107NeoBase 2 Non-derivatized Assay SolutionsWallac OyNQL2019-02-25
06438147356812NeoBase 2 Non-derivatized MSMS kitWallac OyNQL2019-02-25
06438147356829NeoBase 2 Succinylacetone Assay SolutionWallac OyNQL2019-02-25
06438147283842NeoGram Derivatized Assay SolutionsWallac OyNQL2016-02-11
06438147295708NeoBase Succinylacetone Assay Solution Wallac OyNQL2016-02-11
06438147283835NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry KitWallac OyNQL2016-01-12
06438147311859NeoBase Non-derivatized MSMS kitWallac OyNQL2016-01-12