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Mashup Score: 0BioMérieux Gets FDA 510(k) Clearance, CLIA Waiver for Respiratory, Throat Infection PCR Test - 1 month(s) ago
The panel runs on BioMérieux’s SpotFire system for rapid point-of-care molecular diagnostic testing.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 0Cepheid Nabs FDA Clearance for Molecular Group B Strep Test - 2 month(s) ago
The Xpert Xpress assay is a dual-target PCR test intended for the qualitative intrapartum detection of group B Streptococcus.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 2
Ten teams participated in a virtual accelerator designed to help them refine their concepts for detecting active Lyme disease infections.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 0
The panel detects bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis within an hour from a single sample.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 0MedMira Gets FDA 510(k) Clearance for HIV-2 Claims for HIV-1/2 Test - 5 month(s) ago
The firm is also seeking CLIA-waived status to expand access to its HIV-1/2 test that can be used to detect a broader range of HIV subtypes circulating in the US.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 0
Quest will perform HCV antibody testing and molecular RNA testing on deidentified remnant specimens randomly selected from clinical test specimens.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 1
The test is the second home-based COVID-19 test to successfully go through traditional FDA premarket review and the first home-based antigen test to receive FDA clearance.
Source: www.360dx.comCategories: General Medicine News, Infectious DiseaseTweet
BioMérieux Gets FDA 510(k) Clearance, CLIA Waiver for Respiratory, Throat Infection PCR Test https://t.co/IIGwjNaKEt