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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, fetal fibronectin
Product CodeLKV
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 5 2 3 2 0

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Premature Labor 1 1

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