CARBON DIOXIDE L3K Assay 299-17

GUDID 00628063400287

SEKISUI DIAGNOSTICS, LLC

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• Primary Device ID: 00628063400287
• NIH Device Record Key: 41f852e9-c6c0-4e1b-aa04-80a8ae6a34c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBON DIOXIDE L3K Assay
• Version Model Number: 299-17
• Catalog Number: 299-17
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 5
• 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	00628063400287 [Primary]
GS1	10628063400284 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042362

FDA Product Code

• KHS: ENZYMATIC, CARBON-DIOXIDE

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: 2019-10-21
• Device Publish Date: 2016-09-20

On-Brand Devices [CARBON DIOXIDE L3K Assay]

• 00628063400317: 299-80
• 00628063400300: 299-55
• 00628063400294: 299-30
• 00628063400287: 299-17