FDA.reportPublic FDA data

Neonatal Biotinidase kit

Primary DI
06438147291342
Brand
Neonatal Biotinidase kit
Company
Wallac Oy
Model
3018-0010
Catalog number
3018-0010
Device description
For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages.
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
NAKSystem,Test,Biotinidase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAKSystem, Test, BiotinidaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090123000NEONATAL BIOTINIDASE KIT, MODEL 3018Perkinelmer, Inc.2010-03-05NAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147291342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147291342064381472913426438147291342

GMDN Terms#

Term, Definition table
TermDefinition
Biotinidase IVD, kit, enzyme fluorescenceA collection of reagents and other associated materials intended to be used for the quantitative measurement of the enzyme biotinidase in a clinical specimen, using an enzyme fluorescence method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-16 Degrees Celsius
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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Primary DI, Brand, Model table
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06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00725609000076SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000083SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000137SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000144SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000229SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000236SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000243SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000250SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
06438147291359Neonatal Biotinidase kit Wallac OyNAK2016-01-12
06438147330911GSP Neonatal Biotinidase kitWallac OyNAK2016-01-12