Home GUDID 00863840000223 QuantideX qPCR BCR-ABL IS Kit
Primary DI 00863840000223
Brand QuantideX qPCR BCR-ABL IS Kit
Company ASURAGEN, INC.
Model 49574
Catalog number 49574
Published 2019-10-10
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 Code Name OYX Bcr/Abl1 Monitoring Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYX Bcr/Abl1 Monitoring Test Medical Genetics 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00863840000223 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 00863840000223 00863840000223 863840000223 0863840000223
GMDN Terms# Term, Definition table Term Definition Philadelphia chromosome/BCR-ABL transcript 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 chronic myeloid leukaemia (CML) or a subset of acute lymphoblastic leukaemia (ALL) associated with the Philadelphia chromosome, resulting from translocation t(9;22)(q34;q11) and rearrangement of the BCR and ABL genes, using a nucleic acid technique (NAT).
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 00863840000254 AmplideX Fragile X Dx & Carrier Screen Kit 49591 49591 2020-04-07
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07332940007102 Xpert BCR-ABL Ultra CEPHEID OYX 2019-10-25 B60290100280 MRDx BCR-ABL Test MOLECULARMD CORP. OYX 2018-03-07