Quidel Corporation
FDA 510(k) medical device clearances.
Top product codes for Quidel Corporation
Recent clearances by Quidel Corporation
- K231795 — QuickVue COVID-19 Test
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- K230349 — Lyra RSV+hMPV Assay
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
- K230236 — Lyra Influenza A+B Assay
- K211342 — Sofia 2 Campylobacter FIA
- K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set
- K181029 — Solana Bordetella Complete Assay
- K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
- K180288 — QuickVue Influenza A+B
- K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer
- K173250 — Solana GBS Assay
- K163713 — Sofia Lyme FIA, Sofia Lyme Control Set
- K171974 — Solana RSV+hMPV Assay
- K170491 — Solana C. difficile Assay
- K162438 — Sofia Influenza A+B FIA on Sofia 2
- K162911 — Sofia RSV FIA on Sofia 2 analyzer
- K162451 — Solana HSV 1+2/VZV Assay
- K162274 — Solana Strep Complete Assay
- K161814 — Solana Influenza A+B Assay
- K161182 — Solana Trichomonas Assay
- K153012 — Sofia Influenza A+B FIA
- K150868 — Solana GAS Assay, Solana instrument
- K143329 — AmpliVue Trichomonas Assay
- K141775 — SOFIA (R) STREP A+ FIA
- K143206 — AmpliVue Bordetella Assay
- K141927 — LYRA PARAINFLUENZA VIRUS ASSAY
- K141931 — LYRA ADENOVIRUS ASSAY
- K141173 — AMPLIVUE GAS ASSAY
- DEN140005 — LYRA DIRECT STREP ASSAY
- K140029 — AMIPLIVUE HSV 1&2 ASSAY
- K133503 — AMPLIVUE GBS ASSAY
- K131599 — QUICK VUE INFLUENZA
- K123793 — SOFIA STREP A FIA
- K123355 — AMPLIVUE C. DIFFICILE ASSAY
- K102175 — RAPIDVUE HCG TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.