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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device qualitative and quantitative hepatitis b virus antibody assays
Definition In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
Product CodeSEI
Regulation Number 866.3173
Device Class 2

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 1 0 0 0 0

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