DRI Cotinine Assay

GUDID 00884883001053

Microgenics Corporation

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883001053
• NIH Device Record Key: f8e712cc-4702-4208-8cdd-5957276cf1b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Cotinine Assay
• Version Model Number: 0394
• 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	00884883001053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030649

FDA Product Code

• MKU: Enzyme Immunoassasy, Nocotine And Nicotine Metabolites

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-09-22

On-Brand Devices [DRI Cotinine Assay]

• 00884883012905: 10018516
• 00884883002876: 0395
• 00884883001053: 0394