Home GUDID 00863840000254 AmplideX Fragile X Dx & Carrier Screen Kit
Primary DI 00863840000254
Brand AmplideX Fragile X Dx & Carrier Screen Kit
Company ASURAGEN, INC.
Model 49591
Catalog number 49591
Published 2020-04-07
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 OYV Inherited Nucleotide Repeat Disorder Dna Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYV Inherited Nucleotide Repeat Disorder Dna Test Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00863840000254 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 00863840000254 00863840000254 863840000254 0863840000254
GMDN Terms# Term, Definition table Term Definition Fragile X syndrome IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder Fragile X syndrome, using a nucleic acid technique (NAT). The disorder results in mild to moderate mental retardation and is associated with trinucleotide repeat expansion or deletion of the CCG triplet in the FMR1 and/or FMR2 genes located on the X chromosome.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -30 Degrees Celsius -15 Degrees Celsius
Regulatory Flags# DUNS number 622988330 Device count 1 Kit true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850017493087 ROX 1000 Size Ladder A00058 A00058 2023-11-08 00863840000285 RNARetain 84001 84001 2019-11-05 00863840000223 QuantideX qPCR BCR-ABL IS Kit 49574 49574 2019-10-10