Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
The Cell Mediated Immune Response Test for Liver and Small Bowel Transplant is a qualitative prognostic in vitro diagnostic test intended for patients under 21 years of age who have undergone liver or small bowel transplantation, used as an aid in evaluating the risk of acute cellular rejection (ACR) in conjunction with biopsy, standard clinical assessment, and other laboratory information. It is classified as "Not Classified" (Class N) by the FDA and has not been assigned a regulation number or medical specialty. The product code is PHK, reviewed by the Clinical Chemistry (CH) panel. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PHK
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 6
Device Characteristics
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.
Unclassified Reason
9
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.