BUSULFAN QC LEVEL 1

Basic Information

• Brand Name: BUSULFAN QC LEVEL 1
• Primary DI: B80010106500010
• Version / Model: BUS QC 1 F SHP BHM
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-27
• Public Version: 1
• Public Version Date: 2022-08-04
• Public Version Status: New
• Public Device Record Key: ab088164-c4ef-4cdd-88fe-9322e10d8f09

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
LAS	Drug Specific Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66109	Busulfan therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antineoplastic drug busulfan in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B80010106500010	HIBCC
Package	B80010106500011	HIBCC	Box	4	In Commercial Distribution
Package	B80010106500012	HIBCC	Box	5	In Commercial Distribution
Package	B80010106500013	HIBCC	Box	10	In Commercial Distribution
Package	B80010106500016	HIBCC	Box	25	In Commercial Distribution
Package	B80010106500017	HIBCC	Box	50	In Commercial Distribution
Package	B80010106500018	HIBCC	Box	100	In Commercial Distribution

Customer Contacts

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