Revvity (RVTY) said Friday the Food and Drug Administration has cleared EUROIMMUN's automated chemiluminescence-based immunoassay test, which is used for measuring free testosterone levels.
The test is the first FDA-cleared assay for direct measurement of free testosterone in human serum or plasma, the company said.
Revvity said that the test delivers results in 48 minutes with a output of nearly 60 tests per hour.
The assay is designed to diagnose androgen disorders, including hypogonadism, impotence, and polycystic ovarian syndrome, Revvity said.
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