124 results
·
73ms
·
Sources: EU EUDAMED, US FDA
QuickVue
FDA UDI
QUIDEL CORPORATION·30014613201939·QkVue RSV 20T
QuickVue
FDA UDI
QUIDEL CORPORATION·30014613339373·QuickVue® SARS Antigen Test
QuickVue
FDA UDI
QUIDEL CORPORATION·30014613320104·QkVue H pylori gII 30T
Sofia
FDA UDI
QUIDEL CORPORATION·30014613202981·Sofia Lyme FIA
Lyra
FDA UDI
QUIDEL CORPORATION·30014613311140·Lyra Parainfluenza Assay
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
Sofia Strep A+ FIA, Sofia 2 Analyzer
FDA 510(k)
FDA Class 1
·Microbiology
Solana GAS Assay, Solana instrument
FDA 510(k)
FDA Class 2
·Microbiology
Solana GBS Assay
FDA 510(k)
FDA Class 1
·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 GBS ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Sofia 2 Campylobacter FIA
FDA 510(k)
FDA Class 1
·Microbiology