QMS Zonisamide Assay

GUDID 00884883012714

Microgenics Corporation

Zonisamide therapeutic drug monitoring IVD, kit, fluorescent immunoassay

• Primary Device ID: 00884883012714
• NIH Device Record Key: 4fc478bc-aa96-41e5-a41c-c3e0d0aa5af9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMS Zonisamide Assay
• Version Model Number: 10017230
• 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	00884883012714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051211

FDA Product Code

• NWM: Immunoassay, Anti-Seizure Drug

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: 2019-02-14
• Device Publish Date: 2016-09-12

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