(RTTNews) - Revvity (RVTY) received 510(k) clearance from FDA for EUROIMMUN's automated chemiluminescence-based immunoassay test for free testosterone. The company noted that this is the only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma. The new test comes with the rapid results on EUROIMMUN's ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per hour.
"Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone," said Jonathan Friend, general manager at Revvity's EUROIMMUN US.
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