FDA.reportPublic FDA data

GSP Neonatal GALT kit

Primary DI
06438147321704
Brand
GSP Neonatal GALT kit
Company
Wallac Oy
Model
3303-001U
Catalog number
3303-001U
Device description
For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) activity 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
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl TransferaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100101000GSP NEONATALGALT KIT, MODEL 3303-001UPerkinelmer, Inc.2010-06-11KQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147321704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147321704064381473217046438147321704

GMDN Terms#

Term, Definition table
TermDefinition
Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescenceA collection of reagents and other associated materials intended to be used for the quantitative measurement of galactose-1-phosphate uridyl transferase (G1PUT), also known as galactose transferase (GALT) enzyme, 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, Company table
Primary DIBrandCompanyProduct codePublished
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00725609000052SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000069SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
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00725609000120SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
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00725609000168SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000175SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000182SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
06438147001262Neonatal GALT kitWallac OyKQP2016-02-02
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