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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device menopause test system
Definition A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.
Product CodeQDH
Regulation Number 862.1093
Device Class 2


Premarket Reviews
ManufacturerDecision
ANSH LABS LLC
  GRANTED 1

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