DC-UIBC-CAL SE-090

GUDID 00628063401024

SEKISUI DIAGNOSTICS, LLC

Unsaturated iron binding capacity (UIBC) IVD, calibrator

• Primary Device ID: 00628063401024
• NIH Device Record Key: 999aa16f-fdf4-4fc8-a3bc-aef661e1ae06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-UIBC-CAL
• Version Model Number: SE-090
• Catalog Number: SE-090
• 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	00628063401024 [Primary]
GS1	10628063401021 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163078

FDA Product Code

• JIT: CALIBRATOR, SECONDARY

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: 2017-03-06

On-Brand Devices [DC-UIBC-CAL]

• 00628063401024: SE-090
• 00628063400478: SE-090