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U.S. Department of Health and Human Services

Product Classification
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Device peripheral blood processing device for osteoarthritis
Definition Preparation of autologous anti-inflammatory (AAI) solution from a small sample of peripheral blood for treatment of osteoarthritis.
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methods to separate the whole blood into components, after which the autologous anti-inflammatory (AAI) solution is withdrawn.
Target Area Blood drawn from peripheral veins, AAI applied to the joint via intra-articular injection.
Review Panel Hematology
Product CodePZT
Premarket Review Center for Biologics Evaluation & Research (CBER)
Not Classified Reason For Export Only
Submission Type Contact ODE
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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