Bun Rate Reagent

Basic Information

• Brand Name: Bun Rate Reagent
• Primary DI: 00817238010820
• Version / Model: R82043
• Company Name: CLINIQA CORPORATION
• Labeler DUNS: 078742335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 5
• Public Version Date: 2019-02-04
• Public Version Status: Update
• Public Device Record Key: b4fe56b6-f542-46ad-bd6c-300ced8f5a0b

Device Description

Bun Rate Reagent

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes

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
53590	Urea IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817238010820	GS1

Premarket Submissions

Submission Number	Supplement Number
K012649	000