FDA.reportPublic FDA data

SPOTCHECK

Primary DI
00725609000595
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
81-2500-05K
Catalog number
81-2500-05K
Device description
Total Galactose Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Total Galactose (Galactose and Galactose-1-Phosphate) Levels in Neonates
Published
2020-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K991498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991498000ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGALNeometrics, Inc.1999-06-16JIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725609000595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000595007256090005957256090005950725609000595

GMDN Terms#

Term, Definition table
TermDefinition
Total galactose IVD, kit, enzyme spectrophotometryA 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 spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623238615
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00725609000076SPOTCHECK80-8000-13K80-8000-13K2016-10-14
00725609000083SPOTCHECK80-8000-CA80-8000-CA2016-10-14
00725609000090SPOTCHECK81-2000-20K81-2000-20K2016-10-14
00725609000106SPOTCHECK81-2000-60K81-2000-60K2016-10-14
00725609000113SPOTCHECK81-4000-20K81-4000-20K2016-10-14
00725609000120SPOTCHECK81-4000-60K81-4000-60K2016-10-14
00725609000137SPOTCHECK81-8000-13K81-8000-13K2016-10-14
00725609000144SPOTCHECK81-8000-60K81-8000-60K2016-10-14
00725609000199Accuwell6020-20-EGAL6020-20-EGAL2016-10-14
00725609000205SPOTCHECK80-0900-01K80-0900-01K2016-10-14
00725609000212SPOTCHECK80-0901P4K80-0901P4K2016-10-14
00725609000267SPOTCHECK910-0500-00910-0500-002016-10-14
00725609000441SPOTCHECK80-0900P4K80-0900P4K2016-10-14
00725609000458SPOTCHECK80-0901-01K80-0901-01K2016-10-14
00725609000274SPOTCHECK302-A100-03302-A100-032016-10-14
00725609000281SPOTCHECK302-A100-03EX302-A100-03EX2016-10-14
00725609000298SPOTCHECK303-A000-03303-A000-032016-10-14
00725609000304SPOTCHECK303-A002-03303-A002-032016-10-14
00725609000311SPOTCHECK303-A003-03303-A003-032016-10-14
00725609000328SPOTCHECK303-A004-03303-A004-032016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817830023099MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023105MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
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
06438147367917GSP Neonatal Total Galactose kitWallac OyJIA2021-06-04
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