19 April 2018
SpeeDx receives FDA listing for Mycoplasma genitalium product
SpeeDx’s ResistancePlus® MG Positive Control kit has now been listed with the US Food and Drug Administration (FDA) for sale in the United States through the company’s recently incorporated US entity, SpeeDx Inc. The announcement coincides with the FDA registration of the Australian parent company – SpeeDx Pty Ltd – as a Medical Device Manufacturing Establishment.
Read the full press release here