PHK — Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation Class N
FDA product code PHK covers "Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PHK
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
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.