PFK — Quality Control For Molecular Immunohematology Tests Class II
FDA product code PFK covers "Quality Control For Molecular Immunohematology Tests", a Class II medical device regulated under 21 CFR 864.9650. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- PFK
- Device Class
- Class II
- Regulation Number
- 864.9650
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.