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# Qualigen 510(k) for FastPack IP Sex Hormone Assay
- URL: https://www.fdaweb.com/qualigen-510-k-for-fastpack-ip-sex-hormone-assay/
- Published: 2018-10-09T12:00:00.000Z
- Updated: 2026-09-15T00:36:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142543

Qualigen has submitted a 510(k) for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay, indicated for the quantitative determination of SHBG in human serum and plasma as an aid in diagnosing androgen disorders. “When used in conjunction with our currently available FastPack Total Testosterone Assay, it will provide clinicians with a more complete picture of their patients’ androgen status, particularly in the area of men’s health and testosterone deficiency,” the company says. The FastPack device is an immunoassay analyzer that features one-touch operation to also deliver values for vitamin D, thyroid stimulating hormone, free thyroxine, prostate specific antigen, testosterone and human chorionic gonadotropin.