DAT Opiates Multi Control I Set

Basic Information

• Brand Name: DAT Opiates Multi Control I Set
• Primary DI: 00850624008285
• Version / Model: 09330119190
• Catalog Number: 09330119190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Labeler DUNS: 840839190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-18
• Public Version: 1
• Public Version Date: 2021-10-26
• Public Version Status: New
• Public Device Record Key: 437cd0a6-48fc-4265-bc99-5cca8ca651f7

Device Description

Multi-analyte Negative Control (2 x 15 mL) Multi-analyte Positive Control (2 x 15 mL)

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: 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
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	00850624008285	GS1

Storage Conditions

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