URIC ACID-SL Assay 237-60

GUDID 00628063400997

SEKISUI DIAGNOSTICS, LLC

Uric acid IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063400997
• NIH Device Record Key: 5c2099dd-0533-4be0-b68f-a6c629892b9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URIC ACID-SL Assay
• Version Model Number: 237-60
• Catalog Number: 237-60
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 2
• 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	00628063400997 [Primary]
GS1	10628063400994 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961586

FDA Product Code

• KNK: Acid, uric, uricase (colorimetric)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [URIC ACID-SL Assay]

• 00628063401000: 237-99
• 00628063400997: 237-60