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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunohistochemistry assay, antibody, met
Regulation Description Immunohistochemistry reagents and kits.
Definition The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodeSER
Regulation Number 864.1860
Device Class 3

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

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