PBC — Manual Blood Grouping And Antibody Test Systems Class II
FDA product code PBC covers "Manual Blood Grouping And Antibody Test Systems", a Class II medical device regulated under 21 CFR 864.9175. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- PBC
- Device Class
- Class II
- Regulation Number
- 864.9175
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.