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U.S. Department of Health and Human Services

Product Classification

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Device quality control for molecular immunohematology tests
Regulation Description Quality control kit for blood banking reagents.
Definition The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
Physical State DNA or synthetic plasmids
Technical Method Molecular
Target Area N/A
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodePFK
Premarket Review Center for Biologics Evaluation and Research Branch (CBER)
CBER Division (CBER)
Submission Type 510(k)
Regulation Number 864.9650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons