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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


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 3
Inadequate training 1
Total Device Problems 4

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