Direct Bilirubin LiquiColor® 0245-250

GUDID 00657498000571

For the Quantitative Colorimetric Determination of Direct Bilirubin in Serum or Plasma.

STANBIO LABORATORY, L.P.

Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry Conjugated (direct) bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 00657498000571
• NIH Device Record Key: 931bca6c-2aa4-4981-9ac3-bfe0cd9068d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Bilirubin LiquiColor®
• Version Model Number: 0245-250
• Catalog Number: 0245-250
• 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: false
• 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
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000571 [Primary]

FDA Product Code

• CIG: Diazo Colorimetry, 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 [Direct Bilirubin LiquiColor®]

• 00657498000571: For the Quantitative Colorimetric Determination of Direct Bilirubin in Serum or Plasma.
• 00657498000564: For the quantitative colorimetric determination of Direct Bilirubin in Serum and Plasma.