Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures.
POINTE SCIENTIFIC BUN Standard - B7550-STD
Device Description
A material which is used to establish known points of reference for an assay 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.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CDQ
Device Name: Urease And Glutamic Dehydrogenase, 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 Identifiers
Device Id: 00811727010575
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