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Medical Devices / Submissions and Approvals

Thermo Scientific’s CEDIA Buprenorphine II Assay Receives FDA Clearance and CE Mark

June 13, 2017
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Thermo Scientific’s CEDIA Buprenorphine II assay has received FDA marketing clearance, registration in Canada, Australia, and New Zealand, as well as CE Mark and registration in various countries in the European Union.

This immunoassay is designed for the specific detection of buprenorphine and its three major metabolites—b uprenorphine-β-D-glucuronide, norbuprenorphine and norbuprenorphine-β-D-glucuronide.

Buprenorphine is an alternative to methadone in the treatment of opioid addiction.

The assay has no significant cross-reactivity to other opioids and can accurately differentiate buprenorphine treatment samples from slow-release oral morphine treatment samples. — Cynthia Jessup

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