Immunalysis Fentanyl Urine Test Scores 510(k) Approval

August 2, 2017

Alere division Immunalysis announced the FDA has granted 510(k) clearance to its Sefria fentanyl enzyme immunoassay.

Fentanyl immunosay tests have previously only been available for forensic testing. The Sefria test will make fentanyl screening available for hospitals, doctors’ offices and other healthcare settings.

Fentanyl abuse is a major driver of the opioid addiction epidemic, with death rates from synthetic opioids increasing nearly 75 percent between 2014 and 2015.

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