Total Bilirubin LiquiColor® 0230-450

GUDID 00657498000588

The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

STANBIO LABORATORY, L.P.

Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00657498000588
• NIH Device Record Key: 2f5a51e7-c623-4bda-97d8-4eac9d1fe18c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Bilirubin LiquiColor®
• Version Model Number: 0230-450
• Catalog Number: 0230-450
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: false
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000588 [Primary]

FDA Product Code

• JFM: Enzymatic Method, Bilirubin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Total Bilirubin LiquiColor®]

• 00657498000595: For the Quantitative Colorimetric Determination of Total Bilirubin in Serum or Plasma.
• 00657498000588: The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels