Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 30 ml

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 30 ml
Pointe Scientific, Inc. - 13-B7552-R2-30

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: 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 Id: 00811727013903

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