PFK

Quality Control For Molecular Immunohematology Tests

Product code: PFK
Device name: Quality Control For Molecular Immunohematology Tests
Device class: Class 2
21 CFR: 21 CFR 864.9650
Medical specialty: Hematology
Marketing pathway: 510(K)
Flag: Third-party review eligible

FDA classification definition

The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PFK

Classification and pathway per current FDA publications. Data from openFDA (CC0).