BUN3 (Blood Urea Nitrogen)
CAROLINA LIQUID CHEMISTRIES CORP.™ BUN REAGENT 88806 - 88806
Device Description
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.
Environmental Conditions
- Reagent is stable on board a clinical analyzer for 30 days when stored at room temperature (18 - 25° C)
- Unopened Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Total Volume: 500 Milliliter
- Kit contains 1 R1 bottle and 1 package insert
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CDS
Device Name: Electrode, Ion Specific, Urea Nitrogen
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1770
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302020397
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A