Home GUDID 00725609000601 SPOTCHECK
Primary DI 00725609000601
Brand SPOTCHECK
Company ASTORIA-PACIFIC, INC.
Model 81-1100-05K
Catalog number 81-1100-05K
Device description Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates
Published 2020-12-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00725609000601 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00725609000601 00725609000601 725609000601 0725609000601
GMDN Terms# Term, Definition table Term Definition Phenylalanine IVD, kit, enzyme fluorescence A collection of reagents and other associated materials intended to be used for the quantitative measurement of phenylalanine in a clinical specimen, using an enzyme fluorescence method.
Regulatory Flags# DUNS number 623238615 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817830022320 Neonatal Phenylalanine ELISA Kit (without membrane) MP BIOMEDICALS, LLC JNB 2016-10-20 00817830022337 Neonatal Phenylalanine ELISA Kit (with membrane) MP BIOMEDICALS, LLC JNB 2016-10-20 00817830022344 Neonatal Phenylalanine ELISA Kit (without membrane) MP BIOMEDICALS, LLC JNB 2016-10-20 00817830022351 Neonatal Phenylalanine ELISA Kit (with membrane) MP BIOMEDICALS, LLC JNB 2016-10-20 00725609000007 SPOTCHECK ASTORIA-PACIFIC, INC. JNB 2016-10-14 00847817021527 Quantase BIO-RAD LABORATORIES, INC. JNB 2016-09-12 06438147001286 Neonatal Phenylalanine kit Wallac Oy JNB 2016-02-02 06438147001293 Neonatal Phenylalanine kit Wallac Oy JNB 2016-02-02