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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device placental alpha microglobulin-1 immunoassay
Definition A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.
Product CodeQBB
Device Class 3

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

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