QHS — Anti-Human Globulin Class U
FDA product code QHS covers "Anti-Human Globulin", a Class U medical device regulated under 21 CFR 660.50. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- QHS
- Device Class
- Class U
- Regulation Number
- 660.50
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology