Quidel Corporation engages in developing, manufacturing, and marketing rapid diagnostic testing solutions. The company’s diagnostic testing solutions primarily include applications in infectious diseases, women’s health, and gastrointestinal diseases. The company sells its products directly to end users and distributors, in each case, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, universities, retail clinics, and wellness screening centers. It markets its products in the United States through a network of national and regional distributors, and a direct sales force. Internationally, the company sells and markets primarily in Japan and Europe through distributor arrangements. Products The company provides diagnostic testing solutions under various brand names, including QuickVue, QuickVue+, Quidel, MicroVue, FreshCells, D3 FastPoint, Super E-Mix, ELVIS, Sofia, Quidel Molecular, Amplivue, and Thyretain. Its diagnostic testing solutions address the following medical and wellness categories: Infectious Diseases QuickVue Influenza: The company’s QuickVue influenza tests are rapid, qualitative tests for the detection of the viral antigens of influenza type A and B, the two types of the influenza virus. Its first QuickVue influenza test received the U.S. Food and Drug Administration (FDA) clearance. Its second generation test, the QuickVue Influenza A+B test, which allows for the differential diagnosis of influenza type A and type B, received FDA clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver. Group A Strep: The company’s QuickVue Strep A tests are intended for the rapid, qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies recovered from culture. The tests are used to aid in the diagnosis of Group A Streptococcal infection. Group A Streptococci are bacteria that cause illnesses, such as tonsillitis and pharyngitis, which if left untreated, could progress to secondary complications. The company’s initial Strep A test, the QuickVue In-line Strep A test, is the first rapid Strep A test to be granted a CLIA waiver, and it launched additional product offerings with the QuickVue+ Strep A and the QuickVue Dipstick Strep A tests. Respiratory Syncitial Virus (RSV) Test: The company’s QuickVue RSV test is a rapid immunoassay for RSV. The company received 510(k) clearance for the sale of its QuickVue RSV 10 test. QuickVue RSV 10 detects the RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six. QuickVue RSV 10 employs the identical test method and sample preparation of the company’s QuickVue Influenza A+B test, allowing for the use of the same nasopharyngeal patient specimen when testing for influenza or an RSV infection. Multiplex Respiratory: The company’s cell culture and direct fluorescent assays (DFA) detection solutions are used by reference laboratories, public health labs, and acute care hospitals to detect seven major viral respiratory pathogens. Its proprietary cell culture platform R-Mix combined with its FDA cleared antibody kit D3 Ultra DFA, detects Influenza A and B, RSV, Adenovirus and Parainfluenza types 1, 2 and 3, with turn-around times between 16 and 48 hours. The same D3 Ultra DFA antibody kit could also be used for direct specimen testing for those viruses with turn-around times in approximately 90 minutes. The company offers a new FDA cleared technology called D3 FastPoint that detects eight viruses, with Human Metapnuemo Virus added to the testing menu. D3 FastPoint provides laboratories, in a direct specimen testing format, the ability to produce virus identification in approximately 25 minutes from specimen receipt. General Virology: The company provides various traditional cell lines, specimen collection devices, media, and controls for use in laboratories that culture and test for normal human viruses. It provides cell-based products under the FreshCells brand in multiple different formats, including tubes, shell vials, and multi-well pl