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 Virus
[Corrected] September 2, 2009
ATHENS, Ohio – Diagnostic Hybrids announces a correction of the press release dated August 31, 2009 entitled ”Diagnostic Hybrids Gets FDA Clearance for the Detection of Influenza A (H1N1)v Virus.“ Diagnostic Hybrids wishes to clarify that no new claims or new intended use have been cleared by the FDA for the D3 UltraTM DFA Respiratory Virus Identification Kit.
Corrected Press release follows:
The D3 Ultra kit has been shown to detect the 2009 H1N1 influenza A virus in two culture isolates; the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza A virus have not been established. The D3 Ultra kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.
"The D3 Ultra kit is the only commercially available monoclonal antibody screening kit for the detection and identification of influenza A virus as well as influenza B virus, RSV, adenovirus, and parainfluenza virus types 1, 2, and 3. The kit can be used to test all types of respiratory specimen types (i.e. nasopharyngeal swabs and aspirates), by either direct detection or cell culture isolate identification. Confirmation of the D3 Ultra kit’s reactivity to the influenza A virus was critical since the kit serves as an important tool for health care professionals in the diagnosis of their patients, particularly during influenza A outbreak," said Steve Ewers, Senior Product Manager for respiratory products at Diagnostic Hybrids.
The D3 Ultra DFA kit was initially cleared by the FDA in January 2006 for the detection and identification of influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, and parainfluenza virus 1, 2, and 3.
About Diagnostic HYBRIDS
Diagnostic HYBRIDS invents, develops, manufactures, and sells innovative diagnostic and analytical products for a wide range of viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases. The company also develops and commercializes innovative and genetically engineered cell-based detection products for the pharmaceutical and biotechnology industry, with an initial focus on pharmacology assays and products that measure drug clearance and anti-viral interventions with drugs and vaccines. The company is certified to ISO 13485 standards and manufactures live continuous and primary cell cultures for clinical diagnostics and pharmacology assays from its headquarters in Athens, OH. Diagnostic HYBRIDS was named one of the 500 Fastest Growing Companies in America in 2004 and 2005 by Inc. Magazine. The company is a pillar member of BioOhio, a statewide organization of bioscience companies accelerating the bioscience and healthcare economy in Ohio. For more information, please visit www.dhiusa.com.
Contact:
Christina Dierkes
Coordinator, Marketing Communications & Public Relations
christina_dierkes@dhiusa.com
p: 740-589-3300
