BIL BR411

GUDID 05055273200850

The device is intended for the quantitative in vitro determination of total and direct bilirubin in serum or plasma.

RANDOX LABORATORIES LIMITED

Conjugated (direct) bilirubin IVD, reagent

• Primary Device ID: 05055273200850
• NIH Device Record Key: e09e6ac1-1ac4-4868-8a13-0c6dd6314645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIL
• Version Model Number: BR411
• Catalog Number: BR411
• 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 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973995

FDA Product Code

• GIG: Hemoglobinometer

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 [BIL]

• 05055273200867: The device is intended for the quantitative in vitro determination of total and direct bilirubin
• 05055273200850: The device is intended for the quantitative in vitro determination of total and direct bilirubin