MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control

GUDID 00884883011946

Microgenics Corporation

Multiple cardiac marker IVD, control

• Primary Device ID: 00884883011946
• NIH Device Record Key: b8fd5a0d-b8d8-4816-8d36-351b7dca8e31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control
• Version Model Number: OCRD-UL
• 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	00884883011946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122291

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: 2017-04-26

On-Brand Devices [MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control]

• 00884883012004: OCRD-MP
• 00884883011991: OCRD-SP
• 00884883011984: OCRD-303
• 00884883011977: OCRD-202
• 00884883011960: OCRD-101
• 00884883011953: OCRD-L
• 00884883011946: OCRD-UL