MAS CardioImmune XL Liquid Assayed Cardiac Marker Control

GUDID 00884883003606

Microgenics Corporation

Multiple cardiac marker IVD, control

• Primary Device ID: 00884883003606
• NIH Device Record Key: 81d6b642-dfc4-4560-af8a-1f92240a1b40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS CardioImmune XL Liquid Assayed Cardiac Marker Control
• Version Model Number: CAI-XL4
• 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	00884883003606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061196

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 CardioImmune XL Liquid Assayed Cardiac Marker Control]

• 00884883004399: 10014182
• 00884883004382: 10014181
• 00884883004375: 10014180
• 00884883004368: 10014179
• 00884883003613: CAI-XLS
• 00884883003606: CAI-XL4
• 00884883002371: CAI-XLL
• 00884883002364: CAI-XL3
• 00884883002357: CAI-XL2
• 00884883002340: CAI-XL1