Urea Nitrogen (BUN) Liqui-UV®

Basic Information

• Brand Name: Urea Nitrogen (BUN) Liqui-UV®
• Primary DI: 00657498001073
• Version / Model: 2020-430
• Catalog Number: 2020-430
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-04-17
• Public Version Status: Update
• Public Device Record Key: 03bc05cc-68d4-4b99-9ba8-48eff28abf23

Device Description

For the Kinetic Quantitative Determination of Urea Nitrogen (BUN) in Serum.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	862.1770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53587	Urea IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00657498001073	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius