The Solana® C. difficile Assay is Quidel's first molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format for diagnosis of a Healthcare Associated Infection (HAI). Other 510(k) cleared Solana molecular diagnostic assays include:
Solana® HSV 1+2/VZV Assay STI Cleared 11/28/16
Solana® Complete (Strep A + C/G) Assay Respiratory Cleared 10/25/16
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Solana® Influenza A+B Assay Respiratory Cleared 09/27/16
Solana® Trichomonas Assay STI Cleared 08/15/16
Solana® Group A Strep Assay Respiratory Cleared 06/23/15
With the Solana franchise, Quidel has broadened its molecular strategy to include instrumented systems, and grown the number of its molecular platforms that are both 510(k) cleared and available commercially. Quidel's other FDA cleared molecular solutions include the AmpliVue® non-instrumented system for lower-volume moderately complex labs, and Lyra® reagents for higher throughput, highly complex laboratories that are compatible with existing PCR infrastructure.
https://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com.
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