MAS Bilirubin Liquid Assayed Bilirubin Control

GUDID 00884883004627

Microgenics Corporation

Total bilirubin IVD, control

• Primary Device ID: 00884883004627
• NIH Device Record Key: c98a9940-ba02-43f1-b5aa-503b0ef1c8ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Bilirubin Liquid Assayed Bilirubin Control
• Version Model Number: 10014431
• 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	00884883004627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031890

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2019-04-30
• Device Publish Date: 2017-09-28

On-Brand Devices [MAS Bilirubin Liquid Assayed Bilirubin Control]

• 00884883004634: 10014432
• 00884883004627: 10014431
• 00884883004610: 10014430