QMS Zonisamide Immunoassay Calibrator

GUDID 00884883011236

Microgenics Corporation

Zonisamide therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00884883011236
• NIH Device Record Key: f18ac650-e9e3-4dba-bb6c-d0207c6caae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMS Zonisamide Immunoassay Calibrator
• Version Model Number: 0373381
• 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	00884883011236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051211

FDA Product Code

• DLJ: Calibrators, Drug Specific

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-09-24

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