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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
2020 5 5
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Negative Result 2 2
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
No Known Impact Or Consequence To Patient 5 5
Fluid Discharge 1 1
Chorioamnionitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II Dec-07-2020
2 Qiagen Sciences LLC II Apr-01-2020
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