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Ovarian Adnexal Mass Assessment Score Test System

FDA product code ONX · 5 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 866.6050
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-09-01 – 2016-06-15

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.

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