Product code OYG
- Device name
- St2 Assay
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1117
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
- Source
- FDA openFDA device classification dataset