Focus Diagnostics announces FDA clearance for Simplexa Group A Strep Direct Kit

Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, today announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit. Simplexa Group A Strep Direct is a real-time polymerase chain reaction assay for the detection of Group A Streptococcus bacteria directly from throat swabs.



from The Medical News http://ift.tt/1HttOeB