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.