FDA product code QHT
Reagent Red Blood Cells
Hematology·Class U·21 CFR 660.30
US regulatory classifications
- US Product Code (FDA)
- QHTView Product Code Classification →
- US Risk Class (FDA)
- Class U
- US Regulation (CFR)
- 21 CFR 660.30View CFR Regulation →
- Medical specialty
- Hematology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
For the detection of or identification of human blood-group antibodies
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About this record
Reagent Red Blood Cells is a medical device type in the Hematology 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.