FDA product code QBG
Assay, Oral Direct Thrombin Inhibitor
Unknown·Class N·21 CFR
US regulatory classifications
- US Product Code (FDA)
- QBGView Product Code Classification →
- US Risk Class (FDA)
- Class N
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
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About this record
Assay, Oral Direct Thrombin Inhibitor is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.