MAS UrichemTRAK Liquid Assayed Urine Control

GUDID 00884883002470

Microgenics Corporation

Multiple urine analyte IVD, control

• Primary Device ID: 00884883002470
• NIH Device Record Key: c98182fb-e481-40f0-b60d-bf6995ff3b34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS UrichemTRAK Liquid Assayed Urine Control
• Version Model Number: UR11001
• 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: true
• 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	00884883002470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031441

FDA Product Code

• JJW: Urinalysis 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: 2019-04-29
• Device Publish Date: 2017-04-26

On-Brand Devices [MAS UrichemTRAK Liquid Assayed Urine Control]

• 00884883002494: UR-MP
• 00884883002470: UR11001