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U.S. Department of Health and Human Services

Product Classification

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Device assay, genotyping, hepatitis c virus
Definition Export only.
Physical State Export Only
Technical Method In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
Target Area Export Only
Review Panel Microbiology
Product CodeOBF
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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