Multi-Analyte DAU Control Set C, Level 1 Control

Basic Information

• Brand Name: Multi-Analyte DAU Control Set C, Level 1 Control
• Primary DI: B07608570
• Version / Model: 0857
• Catalog Number: 0857
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Labeler DUNS: 840839190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-05
• Public Version: 4
• Public Version Date: 2018-08-24
• Public Version Status: Update
• Public Device Record Key: 19e05f63-1c8f-4032-87ee-f657260fce9b

Device Description

15mL/bottle. Concentration of Multi-Analyte: 112.5 ng/mL benzoylecgonine, 375 ng/mL d-methamphetamine, 225 ng/mL methadone, 1500 ng/mL morphine, 150 ng/mL oxazepam, and 150 ng/mL secobarbital.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DIF	Drug Mixture 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
Primary	B07608570	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K133710	000

Storage Conditions

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