Edison Investment Research - OPGEN INC (OPGN) OpGen - First 510(k) filed with the FDA

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Edison Investment Research

Maxim Jacobs

OpGen - First 510(k) filed with the FDA

OpGen has announced that it has filed for 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates with the FDA, with clearance expected by the end of the year. The company continues to expect to file a follow-on De Novo 510(k) submission in Q419 for approval of the Acuitas AMR Gene Panel test in urine samples, with another De Novo 510(k) submission for the Acuitas Lighthouse software soon thereafter or at approximately the same time.

20/05/2019 6 EN

Underlying

OPGEN INC

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US68373L2088 United States

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Maxim Jacobs

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OpGen - First 510(k) filed with the FDA

Opgen Inc: 1 director

OpGen - AMR Gene Panel clearance expected shortly

OpGen - AMR Gene Panel clearance expected shortly

Manx Financial Group - Termination of coverage

musicMagpie - Termination of coverage

Topps Tiles - Accelerating growth through Q125

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