NeoBase 2 Non-derivatized MSMS kit

Primary DI
06438147356812
Brand
NeoBase 2 Non-derivatized MSMS kit
Company
Wallac Oy
Model
3044-001U
Catalog number
3044-001U
Device description
NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations from newborn heel prick blood samples dried on filter paper.
Published
2019-02-25
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
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
K173568000
K193103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173568000NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc.2018-09-04NQL
K193103000NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc.2020-02-07NQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147356812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147356812064381473568126438147356812

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 Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
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
06438147356829NeoBase 2 Succinylacetone Assay SolutionWallac OyNQL2019-02-25
06438147283842NeoGram Derivatized Assay SolutionsWallac OyNQL2016-02-11
06438147295692NeoBase Non-derivatized Assay Solutions Wallac 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