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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, claudin 18
Regulation Description Immunohistochemistry reagents and kits.
Definition The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodeQZJ
Regulation Number 864.1860
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 1 1

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