FDA.reportPublic FDA data

GSP Neonatal Total Galactose kit

Primary DI
06438147367917
Brand
GSP Neonatal Total Galactose kit
Company
Wallac Oy
Model
3309-002U
Catalog number
3309-002U
Device description
For the quantitative determination of total galactose concentration in dried blood.Note: Kit contains multiple packages.
Published
2021-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JIAEnzymatic Methods, Galactose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIAEnzymatic Methods, GalactoseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190335000GSP Neonatal Total Galactose kitPerkinelmer, Inc.2019-11-06JIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147367917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147367917064381473679176438147367917

GMDN Terms#

Term, Definition table
TermDefinition
Total galactose IVD, kit, enzyme fluorescenceA collection of reagents and other associated materials intended to be used for the quantitative measurement of total galactose (galactose and galactose-1-phosphate) in a clinical specimen, using an enzyme fluorescent 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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817830023112MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023129MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00840239014863Galactose (with Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014870Galactose (without Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014887Galactose (with Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014894Galactose (without Membrane Plate) ELISADRG International IncJIA2021-06-07
00725609000595SPOTCHECKASTORIA-PACIFIC, INC.JIA2020-12-17
06438147275281Neonatal Total Galactose kit Wallac OyJIA2017-05-02
06438147328031GSP Neonatal Total Galactose Kit Wallac OyJIA2017-05-02
00725609000090SPOTCHECKASTORIA-PACIFIC, INC.JIA2016-10-14
00725609000106SPOTCHECKASTORIA-PACIFIC, INC.JIA2016-10-14
00725609000199AccuwellASTORIA-PACIFIC, INC.JIA2016-10-14