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Medical Devices / Submissions and Approvals

FDA Clears Qualigen’s SHBG Test

Feb. 1, 2019

The FDA granted 510(k) clearance to Qualigen’s FastPack IP sex hormone binding globulin (SHBG) immunoassay.

The protein SHBG is an important biomarker used in diagnosis and treatment of certain conditions. A high SHBG level indicates that less free testosterone may be available to tissues than is indicated by a testosterone test.

SHBG controls the amount of testosterone body tissues can issue. Abnormal levels of testosterone can lead to androgen deficiencies, hypogonadism and other conditions.

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