QuantideX qPCR BCR-ABL IS Kit

Basic Information

• Brand Name: QuantideX qPCR BCR-ABL IS Kit
• Primary DI: 00863840000223
• Version / Model: 49574
• Catalog Number: 49574
• Company Name: ASURAGEN, INC.
• Labeler DUNS: 622988330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-10
• Public Version: 2
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 315259e2-f274-4af1-9a5a-0655ad80ef88

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYX	Bcr/Abl1 Monitoring Test	Medical Genetics	866.6060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44431	Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the Philadelphia chromosome, resulting from translocation t(9;22)(q34; q11) and rearrangement of the BCR and ABL genes, to diagnose, monitor or predict chronic myeloid leukaemia (CML) and/or a subset of acute lymphoblastic leukaemia (ALL) in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863840000223	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN160003	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius