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U.S. Department of Health and Human Services

Product Classification

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Device molecular erythrocyte typing test
Definition Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes.
Physical State Solid
Technical Method Molecular
Target Area DNA
Review Panel Hematology
Product CodePEP
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible