MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control

GUDID 00884883005334

Microgenics Corporation

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 00884883005334
• NIH Device Record Key: c5ec132f-0fe0-4ae6-8267-f10288b601f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
• Version Model Number: OPRO-202
• 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	00884883005334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110616

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2019-04-26
• Device Publish Date: 2017-05-01

On-Brand Devices [MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control]

• 00884883005358: OPRO-SP
• 00884883005341: OPRO-303
• 00884883005334: OPRO-202
• 00884883005327: OPRO-101