Research & Development
Qualigen receives US FDA 510(k) acknowledgement for FastPack IP SHBG Immunoassay
10 October 2018 -

Medical device company Qualigen, Inc said on Tuesday that it has submitted a 510(k) notification with the US Food and Drug Administration for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay.

The company has reportedly received the acknowledgement for its SHBG Immunoassay from the US FDA Agency.

This US FDA 510(k) notification allows the commercial use of the FastPack IP SHBG Immunoassay for the quantitative determination of SHBG in human serum and plasma as an aid in the diagnosis of androgen disorders, added the company.

Used in conjunction with the company's currently available FastPack Total Testosterone Assay, the SHBG Immunoassay will provide clinicians with a more complete picture of their patients' androgen status, particularly in the area of men's health and testosterone deficiency, stated CEO Michael S. Poirier.



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