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# Qualigen Sex Hormone Immunoassay Cleared
- URL: https://www.fdaweb.com/qualigen-sex-hormone-immunoassay-cleared/
- Published: 2019-01-31T12:00:00.000Z
- Updated: 2026-09-15T00:59:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143265

FDA has cleared a Qualigen 510(k) for its FastPack IP Sex Hormone Binding Globulin Immunoassay, a biomarker used in diagnosing and treating men’s health. The FastPack IP system is described by the company as a fully automated, highly efficient blood analyzer that provides rapid, quantitative immunoassay results at the push of a button. It features an all inclusive reagent pack and provides results within 12 minutes, Qualigen says.