chemiluminescence based immunoassay for free testosterone: FDA status

Approved Approved Jan 10, 2025. Indication: quantitative measurement of free testosterone in serum or plasma for hypogonadism and impotence evaluation. Company: Revvity / EUROIMMUN.

Regulatory history

• Jan 10, 2025: 510(k) clearance. Revvity announced FDA 510k clearance for EUROIMMUN automated ChLIA free testosterone test, the first FDA cleared test for direct free testosterone measurement urologytimes.com

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