SEKISUI Diagnostics announces the launch of the OSOM COVID-19 Antigen Home Test to diagnose COVID-19 at home.
| BURLINGTON, Mass., July 31, 2023 /PRNewswire/ -- SEKISUI Diagnostics announces the launch of the OSOM COVID-19 Antigen Home Test to diagnose COVID-19 at home.
The OSOM COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 virus. As with other OSOM Rapid Tests, it is made in the USA and supported by a highly skilled technical support team of medical technologists/professionals. “We are excited to be able to provide consumers with more tools to help diagnose COVID-19 in a fast, easy-to-use format that can be purchased over the counter. This supports our goal of bringing diagnostics to where they are needed most, which in this case is at home, so people do not have to travel to medical facilities and can treat or quarantine quickly”, said Erica Blight, VP of Client Services, Clinical Research & Marketing. SEKISUI Diagnostics is a well-known provider of many rapid testing solutions to the professional market through a portfolio of point-of-care tests under the OSOM and Acucy® brands. These simple, high performing tests have provided flexibility to healthcare professionals for decades and are now being brought to the home testing market. “Our entrance into the home testing market is another way we are providing solutions to enhance life with science to improve the health of all people. We understand home testing is a valuable tool and becoming more accepted and necessary, especially when we are experiencing significant waves of respiratory infections as we have seen in previous seasons”, said Bob Schruender, President & CEO. About the OSOM® COVID-19 Antigen Home Test This product has not been FDA cleared or approved but has been authorized by FDA under a conditional EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and the conditional emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. About SEKISUI Diagnostics: With over 40 years of experience, SEKISUI Diagnostics’ mission is to provide intelligent solutions to enhance life with science and improve the health of all people. We supply innovative medical diagnostics globally to physicians, hospitals, laboratories and alternate testing locations. Our product lines include clinical chemistry reagents, point-of-care tests, pre-analytic systems as well as enzymes and specialty biochemicals.
SOURCE SEKISUI DIAGNOSTICS, LLC |
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