11 results
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52ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa COVID-19 & Flu A/B Direct
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa COVID-19 Direct
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology