Uric Acid LiquiColor® 1045-430

GUDID 00657498001103

Quantitative Enzymatic Colorimetric Determination of Uric Acid in Serum, Plasma or Urine.

STANBIO LABORATORY, L.P.

Uric acid IVD, kit, enzyme spectrophotometry Uric acid IVD, kit, enzyme spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry Uric acid IVD, kit, spectrophotometry

• Primary Device ID: 00657498001103
• NIH Device Record Key: 36fb7a50-0a36-47e0-a899-9d3f9711a28a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uric Acid LiquiColor®
• Version Model Number: 1045-430
• Catalog Number: 1045-430
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	00657498001103 [Primary]

FDA Product Code

• KNK: Acid, Uric, Uricase (Colorimetric)

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: 2018-04-16
• Device Publish Date: 2016-09-23

On-Brand Devices [Uric Acid LiquiColor®]

• 00657498001110: Quantitative Enzymatic Colorimetric Determination of Uric Acid in Serum, Plasma or Urine.
• 00657498001103: Quantitative Enzymatic Colorimetric Determination of Uric Acid in Serum, Plasma or Urine.