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 Code | ONX |
Regulation Number |
866.6050
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Device Class |
2
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