DRI Ecstasy Plus Assay

GUDID 00884883006751

Microgenics Corporation

Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883006751
• NIH Device Record Key: 372f1240-7be6-4db3-8ce0-a96bc8dca22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Ecstasy Plus Assay
• Version Model Number: 10024631
• 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	00884883006751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012110

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-29
• Device Publish Date: 2018-09-27

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