OPIATE QC MIX

Basic Information

• Brand Name: OPIATE QC MIX
• Primary DI: B800OPIAQCLFCCO0
• Version / Model: OPIA QC L FCCO
• Catalog Number: OPIA QC L FCCO
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-18
• Public Version: 1
• Public Version Date: 2023-05-26
• Public Version Status: New
• Public Device Record Key: b9901c19-6723-461c-9606-4879708823f6

Device Description

OPIATE QC MIX

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
55235	Multiple-therapy 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 multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B800OPIAQCLFCCO5	HIBCC	box	2	In Commercial Distribution
Primary	B800OPIAQCLFCCO0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	25	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius