UIBC-SL 153-30

GUDID 00628063400942

SEKISUI DIAGNOSTICS, LLC

Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

• Primary Device ID: 00628063400942
• NIH Device Record Key: 25249d59-3a40-4861-b282-6028c70e77ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UIBC-SL
• Version Model Number: 153-30
• Catalog Number: 153-30
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 1
• 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	00628063400942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963116

FDA Product Code

• JMO: Ferrozine (colorimetric) iron binding capacity

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: 2016-09-16

On-Brand Devices [UIBC-SL]

• 00628063400959: 153-50
• 00628063400942: 153-30
• 00628063400935: 153-90
• 00628063400928: 153-10