DRI Methadone Metabolite Assay

GUDID 00884883012912

Microgenics Corporation

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883012912
• NIH Device Record Key: ed26b0f5-4d8e-413c-a711-f7261397ae21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Methadone Metabolite Assay
• Version Model Number: 10018522
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00884883012912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023617

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-09-12

On-Brand Devices [DRI Methadone Metabolite Assay]

• 00884883012912: 10018522
• 00884883003408: 100115
• 00884883002920: 100116