Product code QBG
- Device name
- Assay, Oral Direct Thrombin Inhibitor
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
- Source
- FDA openFDA device classification dataset