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U.S. Department of Health and Human Services

Product Classification

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Device peripheral blood processing device for clinical use
Definition Preparation of autologous platelet rich plasma from a small sample of peripheral blood for clinical use
Physical State May include centrifuge, filters, tubes, syringes, needles, other disposables and anticoagulant
Technical Method Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn
Target Area Blood drawn from peripheral veins, PRP applied clinically
Review Panel Hematology
Product CodePZV
Premarket Review Center for Biologics Evaluation & Research (CBER)
Not Classified Reason For Export Only
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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