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Medical Devices / Submissions and Approvals

FDA Clears Campylobacter Diagnostic Assays

Feb. 2, 2018

The FDA cleared two diagnostic tests manufactured by TECHLAB for diagnosing campylobacteriosis, a foodborne illness that causes diarrhea, cramps, fever, and vomiting.

The CAMPYLOBACTER QUIK CHECK can detect Campylobacter jejuni and Campylobacter coli in less than 30 minutes, the company said.

The CAMPYLOBACTER CHECK is designed to aid diagnostic laboratories in testing large numbers of human fecal specimens.

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