Quality Control For Molecular Immunohematology Tests
Medical specialty
Hematology
Device class
2
Regulation number
864.9650
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Definition
The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.