PHK

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

Product code

PHK

Device name

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

Device class

Class N

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

FDA classification definition

The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.

Definition text from the FDA device classification database (U.S. federal government work, public domain).