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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ovarian adnexal mass assessment score test system
Definition An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.
Product CodeONX
Regulation Number 866.6050
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
VERMILLION
  GRANTED 1
VERMILLION, INC.
  SUBSTANTIALLY EQUIVALENT 1

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