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Medical Devices / Submissions and Approvals

FDA Clears Qualigen’s SHBG Test

Feb. 1, 2019
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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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