CEDIA Cocaine OFT Assay

GUDID 00884883011137

Microgenics Corporation

Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

• Primary Device ID: 00884883011137
• NIH Device Record Key: a3bd3bb1-37c3-4bc9-a0e5-2d34ac9d9608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Cocaine OFT Assay
• Version Model Number: 10014764
• 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	00884883011137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101742

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [CEDIA Cocaine OFT Assay]

• 00884883011137: 10014764
• 00884883000834: 10021745
• 00884883000223: 10018590