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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, folr1
Regulation Description Immunohistochemistry reagents and kits.
Definition The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodeQUL
Regulation Number 864.1860
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 1 3 1 2 0

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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