LCO2-2 CD4006

GUDID 05055273208375

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.

RANDOX LABORATORIES LIMITED

Bicarbonate (HCO3-) IVD, reagent

• Primary Device ID: 05055273208375
• NIH Device Record Key: 95677600-2374-437e-b6a7-ad84f0ef1cac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LCO2-2
• Version Model Number: CD4006
• Catalog Number: CD4006
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• 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

Customer Support Contacts

• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273208375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951221

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [LCO2-2]

• 05055273213959: The device is intended for the quantitative in vitro determination of carbon dioxide in serum or
• 05055273208375: The device is intended for the quantitative in vitro determination of carbon dioxide in serum or