CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT AU-252

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT AU-252
• Primary DI: 00817302020373
• Version / Model: AU-252
• Catalog Number: AU-252
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: e1fd51a3-b4dd-44ee-bdca-56829a910118

Device Description

BUN (Blood Urea Nitrogen) 3 x 300 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
63333	Urea IVD, kit, 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 a spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302020373	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	60	Milliliter
Device Size Text, specify			Kit contains 3 R1/R2 bottles and 1 package insert

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Unopened Reagent is stable when stored at 2-8° C until expiration date
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius