OpGen Completes Initial FDA 510(k) Submission for its Acuitas® AMR Gene Panel Test to Identify Presence of Antibiotic Resistance
“We are excited to have completed the first 510(k) submission to the
The performance of the
Our molecular diagnostics and informatics products, product candidates and services combine our Acuitas molecular diagnostics and
The statements in this press release regarding OpGen’s future regulatory submission and clearance plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the success of our commercialization efforts, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with
Source: OpGen, Inc.