Birlinn BCR-ABL1 p210 IS Control Panel C240

Basic Information

• Brand Name: Birlinn BCR-ABL1 p210 IS Control Panel C240
• Primary DI: 00852720008367
• Version / Model: v.00
• Catalog Number: C240
• Company Name: Mmqci
• Labeler DUNS: 172874245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-20
• Public Version: 1
• Public Version Date: 2025-06-30
• Public Version Status: New
• Public Device Record Key: c46f0060-5a5f-4b33-9736-3d2322707fa6

Device Description

External quality controls to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 fusion gene using molecular test systems.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QIG	Quality Control Material, Genetics, Rna	Microbiology	866.5910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47960	Philadelphia chromosome/BCR-ABL transcript IVD, control	A material which is used to verify the performance of an assay 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852720008367	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius