www.fdanews.com/articles/177079-meridian-biosciences-illumigene-mycoplasma-test-nabs-fda-clearance
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Meridian Bioscience’s Illumigene Mycoplasma Test Nabs FDA Clearance
June 15, 2016
The FDA has granted clearance to Meridian Bioscience’s Illumigene Mycoplasma Direct assay for the diagnosis of mycoplasma pneumonia.
The updated assay includes a three-step procedure, producing results in less than an hour, according to the company.
The test uses throat swabs to detect infection on the first day of symptoms. — Anisa Jibrell