Product code PHK
- Device name
- Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset