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Diagnostic Hybrids, Inc. Receives FDA Emergency Use Authorization for D3 Ultra 2009 H1N1 Influenza A Virus ID Kit


2/23/2010 1:06:51 PM

SAN DIEGO--(BUSINESS WIRE)--Diagnostic Hybrids, a Quidel Company (NASDAQ: QDEL) has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its D3® UltraTM 2009 H1N1 Influenza A Virus ID Kit, a monoclonal antibody fluorescent staining kit for the specific identification of 2009 H1N1 influenza A in direct patient specimens or incubated tissue cultures. The D3 Ultra 2009 H1N1 Influenza A Virus ID Kit is to be used for individuals with signs and symptoms of influenza and who previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device such as the D3 Ultra Respiratory Virus Screening and ID Kit. Emergency use authorization allows for the early availability of important diagnostic and therapeutic tools “to diagnose, treat, or prevent serious or life-threatening diseases or conditions […] when there are no adequate, approved and available alternatives.”1

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