This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of ...
BETHLEHEM, Pa., Feb. 22, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick ® HCV Rapid Antibody Test has now been approved by the U.S. Food and Drug ...
The agency announced approval of The OraQuick HCV Rapid Antibody Test, the first rapid blood test for antibodies to the virus for individuals 15 and older. Jun 28, 2010 The Food and Drug ...
BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a ...
The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test which can provide a critical support in expanding access to testing and diagnosis, accelerating global ...
BETHLEHEM, Pa., July 28, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced ...
June 28, 2010 — The US Food and Drug Administration (FDA) has approved the first rapid blood test for antibodies to the hepatitis C virus (OraQuick HCV Rapid Antibody Test; OraSure Technologies, Inc) ...
Says filing for oral version of HCV test delayed Says FDA commented on lower sensitivity of tests Q2 loss/shr $0.01 vs. est loss/shr $0.07 Q2 rev $19.2 mln vs. est $17.5 mln Aug 4 (Reuters) - OraSure ...
August 19, 2011 (Atlanta, Georgia) (UPDATED August 23, 2011) — A new HIV rapid test platform, designed to deliver test results in 10 minutes, may also detect HIV earlier in the course of infection ...
A solid start to 2017 for the diagnostic-test specialist. Revenue increased 12% year over year, with OraQuick HCV sales increasing 111% as international sales more than quadrupled, thanks to a large ...
A search of the Medicines and Healthcare Products Regulatory Agency (MHRA) website revealed no manufacturer Field Safety Notices or Medical Device Alerts for this equipment. No reports of adverse ...
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