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.
January 12, 2010 Diagnostic Hybrids Announces FDA Clearance of D3® FastPointTM L-DFATM RSV/MPV Identification KitDiagnostic Hybrids, a leading developer of in vitro diagnostic fluorescent staining kits and cell culture products, announces the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3® FastPointTM L-DFATM RSV/MPV Identification Kit, which allows for the identification of respiratory syncytial virus and human metapneumovirus from a patient’s specimen in under 25 minutes.
November 18, 2009 Diagnostic Hybrids Sponsored Graves’ Disease Foundation’s Patient and Family Education ConferenceOn October 16, 2009, Diagnostic Hybrids was a presenting corporate sponsor at the 2009 Graves’ Patient and Family Education Conference of the Graves’ Disease Foundation.
October 27, 2009 DHI Announces FDA Clearance of D3® FastPoint L-DFA Influenza A/Influenza B Virus ID KitDiagnostic Hybrids, a leading developer of in vitro diagnostic fluorescent staining kits and cell culture products, announces the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM Influenza A/Influenza B Virus Identification Kit, which allows for the identification of influenza A virus and influenza B virus from a patient’s specimen in under 30 minutes.
September 15, 2009 DHI Sponsored Lissitzky Career Award at 2009 European Thyroid Association Annual MeetingDiagnostic Hybrids was the exclusive sponsor of the Emeritus Lissitzky Career Award at the 34th Annual Meeting of the European Thyroid Association in Lisbon, Portugal. The prize is awarded biannually to a distinguished member of the association who has made life-long contributions to the European thyroid research community.
September 14, 2009 Diagnostic Hybrids Announces FDA Clearance of D3® FastPointTM L-DFATM Respiratory Virus Identification KitDiagnostic Hybrids, a leading developer of IVD fluorescent staining kits and cell culture products, today announced the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPoint L-DFA Respiratory Virus Identification Kit, which allows the individual detection of influenza A, influenza B, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus and parainfluenza viruses from a patient’s specimen in under 30 minutes.
August 31, 2009 DHI Receives Special 510(k) Clearance for an Update to the D3 Ultra DFA Respiratory Virus Identification Kit Package Insert To Include Reactivity with Culture Isolates of 2009 H1N1 Influenza A VirusDiagnostic Hybrids Receives Special 510(k) Clearance for an Update to the D<sup>3</sup> <i>Ultra</i> DFA Respiratory Virus Identification Kit Package Insert To Include Reactivity with Culture Isolates of 2009 H1N1 Influenza A Virus.
August 28, 2009 Ohio Governor Ted Strickland Visits Diagnostic HybridsOhio Governor Ted Strickland and State Representative Debbie Philips visited Diagnostic Hybrids to discuss education reform.
August 24, 2009 Diagnostic HYBRIDS Releases Thyretain™ for Specific Detection of Thyroid Stimulating ImmunoglobulinsDiagnostic HYBRIDS announces the FDA clearance, for marketing under the 510(k) pre-notification process, of the Thyretain TSI Reporter BioAssay.
March 18, 2009 Diagnostic HYBRIDS Receives FDA Clearance For D3 DFA Metapneumovirus Identification KitAthens, OH - Diagnostic HYBRIDS announces the release of its D3 DFA Metapneumovirus Identification Kit for the U.S. market. The kit is the only FDA-cleared device that detects and identifies human metapneumovirus (MPV) from nasal and nasopharyngeal swabs, aspirates and washes using patent-pending MPV monoclonal antibodies.