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Pathway Genomics Gets FDA Registration for Collection Kit

Sep 28, 2011

NEW YORK (GenomeWeb News) – Pathway Genomics today said that the US Food and Drug Administration has classified and registered its saliva collection kit as a Class I exempt device.

The device is used to collect samples for the firm's genetic testing services.

The San Diego-based firm said last week that it had received a CLIA Certificate of Accreditation for its lab from the US Department of Health and Human Services' Centers for Medicare and Medicaid. It also recently received accreditation last month from the College of American Pathologists.

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genetic testing
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