FDA.reportPublic FDA data

NeoBase Non-derivatized MSMS kit

Primary DI
06438147311859
Brand
NeoBase Non-derivatized MSMS kit
Company
Wallac Oy
Model
3040-001U
Catalog number
3040-001U
Device description
For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.
Published
2016-01-12
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
06438147311859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147311859064381473118596438147311859

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
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
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