DRI THC 125 ng/mL Urine Control

GUDID 00884883011533

Microgenics Corporation

Cannabinoid IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control Cannabinoid/cannabinoid metabolite IVD, control

• Primary Device ID: 00884883011533
• NIH Device Record Key: 0e82adf7-70d6-47b5-aa79-478c99e7ac46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI THC 125 ng/mL Urine Control
• Version Model Number: 0212
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883011533 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)
• LAS: Drug Specific Control Materials

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-10-19

On-Brand Devices [DRI THC 125 ng/mL Urine Control]

• 00884883011533: 0212
• 00884883005020: 1404