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NEW YORK (360Dx) – Immunalysis announced on Monday that its Sefria urine-based fentanyl immunoassay has received 510(k) clearance from the US Food and Drug Administration.

The test is designed to qualitatively detect the synthetic opioid fentanyl in urine and is based on Immunalysis' beta-galactosidase enzyme technology. With the FDA clearance, the test is now available to CLIA-certified reference laboratories, hospitals, physician offices, and other healthcare settings that perform moderate complexity testing, Immunalysis said.

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