MGC Primary DAU Control Set

GUDID 00884883001619

Microgenics Corporation

Multiple drugs of abuse IVD, control

• Primary Device ID: 00884883001619
• NIH Device Record Key: 1c2772d3-7995-4697-91d8-17edc982a8bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Primary DAU Control Set
• Version Model Number: 100200
• 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	00884883001619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040758

FDA Product Code

• DIF: Drug Mixture Control Materials

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: 2019-04-24
• Device Publish Date: 2017-09-28

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• 00884883009356 - MAS Omni•IMMUNE PRO Max, Level 2: 2025-08-20
• 00884883009363 - MAS Omni•IMMUNE PRO Max, Level 3: 2025-08-20
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