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news.Ortho Clinical Diagnostics, a developer of in-vitro diagnostic products and a Johnson & Johnson company, has received the 510(k) clearance from the FDA for its Vitros 3600 immunodiagnostic system.
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According to the company, the new high-capacity immunoassay system provides laboratories with a new system to address their quality, labor and cost challenges. The Vitros 3600 is expected to deliver dependable results by offering a broad and comprehensive immunoassay menu based on Vitros technologies.
The Vitros 3600 immunodiagnostic system can be easily integrated with the enGen laboratory automation system and other Vitros Systems, such as the Vitros 5,1 FS Chemistry System, allowing users to easily expand or change modules and interfaces as their needs change, the company said.
This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the Vitros 5600 integrated system in October. Both systems are now commercially available in the US.
Mark Straley, worldwide commercial president of Ortho Clinical Diagnostics, said: The introduction of the Vitros 3600 immunodiagnostic system continues our commitment to go beyond merely improving existing technologies to help clinical laboratories meet their challenges.
We built this new high-capacity system based on a foundation of proven Vitros technologies to give our customers the ability to consistently produce highly accurate test results for high-volume routine immunoassays, such as cardiology, thyroid and endocrinology, and infectious disease immunoassays, such as HIV and hepatitis.