# Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PHK)
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