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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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ACCURUN 365 West Nile Virus RNA Positive Quality Control

Applicant: BBI Diagnostics, A SeraCare Company, West Bridgewater, MA

510(k) number: BK060030

Product: ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV)

Date: 8/18/2006

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