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

SOFIA (R) STREP A+ FIA

FDA 510(k)

FDA Class 1 ·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

SOFIA STREP A FIA

FDA 510(k)

FDA Class 1 ·Microbiology

Solana HSV 1+2/VZV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

QuickVue Influenza A+B

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia RSV FIA on Sofia 2 analyzer

FDA 510(k)

FDA Class 1 ·Microbiology

QUICK VUE INFLUENZA

FDA 510(k)

FDA Class 1 ·Microbiology

Solana C. difficile Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

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

LYRA PARAINFLUENZA VIRUS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDVUE HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry