29 results
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33ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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AMIPLIVUE HSV 1&2 ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Solana RSV+hMPV Assay
FDA 510(k)
FDA Class 2
·Microbiology
AmpliVue Trichomonas Assay
FDA 510(k)
FDA Class 2
·Immunology
AmpliVue Bordetella Assay
FDA 510(k)
FDA Class 2
·Microbiology
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
FDA 510(k)
FDA Class 2
·Microbiology
Sofia Influenza A+B FIA on Sofia 2
FDA 510(k)
FDA Class 2
·Microbiology
Solana Strep Complete Assay
FDA 510(k)
FDA Class 2
·Microbiology
Solana Bordetella Complete Assay
FDA 510(k)
FDA Class 2
·Microbiology
Solana GAS Assay, Solana instrument
FDA 510(k)
FDA Class 2
·Microbiology
Sofia 2 Lyme FIA, Sofia Lyme Control Set
FDA 510(k)
FDA Class 2
·Microbiology
Lyra Influenza A+B Assay
FDA 510(k)
FDA Class 2
·Microbiology
AMPLIVUE GAS ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
QuickVue COVID-19 Test
FDA 510(k)
FDA Class 2
·Microbiology
AMPLIVUE C. DIFFICILE ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Sofia Influenza A+B FIA
FDA 510(k)
FDA Class 2
·Microbiology
LYRA DIRECT STREP ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Solana Trichomonas Assay
FDA 510(k)
FDA Class 2
·Immunology
Solana Influenza A+B Assay
FDA 510(k)
FDA Class 2
·Microbiology
Lyra RSV+hMPV Assay
FDA 510(k)
FDA Class 2
·Microbiology
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
FDA 510(k)
FDA Class 2
·Microbiology