FDA clears Lab21's syphilis test
This article was originally published in Clinica
Executive Summary
UK firm Lab21 has received its first 510(k) clearance from the US FDA, for its syphilis test. The assay detects Treponema pallidum haemagglutination (TPHA) – this bacterium causes the sexually transmitted infection. The Syphilis THPA test runs on Beckman Coulter’s PK7200 platform, and was approved in China in June (www.clinica.co.uk, 4 June 2010). Meanwhile, Cambridge-based Lab21 has launched its cytomegalovirus haemagglutination (CMV HA) assay in Europe, after CE marking the product last month. The test can be carried out on Beckman Coulter’s PK7200 and 7300 systems. CMV generally causes few symptoms, but can lead to significant health problems in immunocompromised people.
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