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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, ki-67
Definition The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodeQQT
Device Class 3

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

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