Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
PHK · Not classified · Unknown
Classification
FDA Product Code
PHK
Device class
Not classified
Regulation
—
Review panel
CH
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.