Flowflex™ is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens within 7 days of symptom onset or without any symptoms. This test is easy to use, accurate and is EUA for ...
新型冠状病毒的全球大流行对于人们日常生活造成了严重影响,各个国家都陷入了对抗病毒肆虐的防疫“战争”中,新冠病毒快速检测试剂作为可大规模筛查并快速出具检测结果,已经成为国际上高度认可的防疫工具。但在该产品上市之初,由于缺乏独立可靠的 ...
The Food and Drug Administration (FDA) has cleared ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, the first over-the-counter (OTC) antigen test. Previously, the test was authorized for ...
(WWTI) — The Food and Drug Administration has issued a recall on the “Flowflex™ SARS-CoV-2 Antigen Rapid Test.” According to the FDA, this test was first recalled in early January by ACON Laboratories ...
The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway. Acon Laboratories secured the 510(k) clearance for its ...
The warning is for the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” from ACON Laboratories. The test comes in a dark blue box with white lettering and symbols in the lower right corner of ...
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