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U.S. Department of Health and Human Services

Product Classification

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Device for export only - antigen, anti-skeletal, indirect fluorescent antibody test system
Review Panel Clinical Chemistry
Product CodeNUL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Third Party Review Not Third Party Eligible
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