Thermo Fisher Scientific Wins 510(k) Approval for Hydrocodone Immunoassay

Thursday, October 29, 2015

Source: FDANEWS

The FDA has granted 510(k) approval to Thermo Fisher Scientific for its immunoassay for specific detection of hydrocodone.

The test specifically detects hydrocodone at the 300 ng/mL cut-off.

Hydrocodone, a cough suppressant and narcotic analgesic agent for the treatment of moderate to severe pain, is considered to be one of the most frequently prescribed and misused opiate drugs in the U.S., the company says.

The assay is said to meet proposed guidelines by the Substance Abuse and Mental Health Administration, which oversees the testing of federally regulated employees

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