Product code QXS
- Device name
- Chromogranin A
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6010
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors.
- Source
- FDA openFDA device classification dataset