CARBON DIOXIDE L3K Assay 299-30

GUDID 00628063400294

SEKISUI DIAGNOSTICS, LLC

Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry Carbon dioxide (CO2) IVD, kit, spectrophotometry

• Primary Device ID: 00628063400294
• NIH Device Record Key: 0060f4db-525c-4c00-a95a-1ac4df264bc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBON DIOXIDE L3K Assay
• Version Model Number: 299-30
• Catalog Number: 299-30
• 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	00628063400294 [Primary]
GS1	10628063400291 [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: 2016-09-16

On-Brand Devices [CARBON DIOXIDE L3K Assay]

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