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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay for detection of amniotic fluid protein(s).
Regulation Description Urinary pH (nonquantitative) test system.
Definition The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
Product CodeNQM
Regulation Number 862.1550
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Chorioamnionitis 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Fluid Discharge 1 1

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