DRUGS OF ABUSE CAL LEVEL 1

Basic Information

• Brand Name: DRUGS OF ABUSE CAL LEVEL 1
• Primary DI: B800DAULLEVEL1V2URMC0
• Version / Model: DAU+ L LEVEL 1 V2 URMC
• Catalog Number: DAU+ L LEVEL 1 V2 URMC
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-09
• Public Version: 1
• Public Version Date: 2023-02-17
• Public Version Status: New
• Public Device Record Key: 25b3e35b-6353-4853-8591-4476aee73f90

Device Description

DRUGS OF ABUSE CAL LEVEL 1

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
55461	Multiple drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B800DAULLEVEL1V2URMC5	HIBCC	Box	25	In Commercial Distribution
Primary	B800DAULLEVEL1V2URMC0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius