OQX — Self-Contained Blood Grouping Class II
FDA product code OQX covers "Self-Contained Blood Grouping", a Class II medical device regulated under 21 CFR 864.9175. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- OQX
- Device Class
- Class II
- Regulation Number
- 864.9175
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
Intended for single use for individual blood group determination for educational and informational purposes