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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, genotyping, hepatitis c virus
Definition In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
Product CodeOBF
Regulation Number 866.3170
Device Class 2

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
3 2 1 0 0 0

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