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Immunalysis Gets FDA Clearance for Fentanyl Test

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.

"The Sefria fentanyl urine drug screening test rounds out our offering of technologically advanced assays for detecting prescription and illegal drugs of abuse by providing clinicians and toxicologists with a relevant menu of FDA-cleared opiate and opioid tests," Kathy Miller, vice president of sales and marketing at Immunalysis, said in a statement.

Immunalysis, a division of Alere, offers tests for alcohol, benzodiazepines, synthetic cannabinoids, and ketamine, as well as metabolites of methadone and heroin. Alere is currently being acquired by Abbott in a deal that is expected to close in the third quarter.