UREA-L3K 283-30

GUDID 00628063400966

SEKISUI DIAGNOSTICS, LLC

Urea IVD, kit, enzyme spectrophotometry Urea IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063400966
• NIH Device Record Key: 5c62f4c0-841d-4dd5-ab9b-036ff558b0a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UREA-L3K
• Version Model Number: 283-30
• Catalog Number: 283-30
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063400966 [Primary]
GS1	10628063400963 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002694

FDA Product Code

• CDQ: UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

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: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [UREA-L3K]

• 00628063400973: 283-99
• 00628063400966: 283-30