Product code NTM
- Device name
- Antigen, Inflammatory Response Marker, Sepsis
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3210
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
- Source
- FDA openFDA device classification dataset