← FDA Medical Device Classifications
Assay, Oral Direct Thrombin Inhibitor
QBG · Not classified · Unknown
Classification
- FDA Product Code
QBG- Device class
- Not classified
- Regulation
- —
- Review panel
- HE
- Medical specialty
- Unknown
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown