For in vitro diagnostic use in the quantitative colorimetric determination of urea nitrogen in serum.

For in vitro diagnostic use in the quantitative colorimetric determination of urea nitrogen in serum.
POINTE SCIENTIFIC BUN (Berthelot) - B7551-120

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CDL

Device Name: Berthelot Indophenol, 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 Id: 00811727010568

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