# Assay, Oral Direct Thrombin Inhibitor
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QBG)
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