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Quidel Corporation

37 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
QuickVue COVID-19 Test (K231795)Quidel Corporation2024-03-22
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (K232286)Quidel Corporation2023-12-20
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (K233688)Quidel Corporation2023-12-13
Lyra RSV+hMPV Assay (K230349)Quidel Corporation2023-03-10
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039)Quidel Corporation2023-03-08
Lyra Influenza A+B Assay (K230236)Quidel Corporation2023-03-03
Sofia 2 Campylobacter FIA (K211342)Quidel Corporation2021-11-23
Sofia 2 Lyme FIA, Sofia Lyme Control Set (K173496)Quidel Corporation2018-08-30
Solana Bordetella Complete Assay (K181029)Quidel Corporation2018-07-15
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (K173691)Quidel Corporation2018-02-28
QuickVue Influenza A+B (K180288)Quidel Corporation2018-02-13
Solana GBS Assay (K173250)Quidel Corporation2017-12-21
Sofia Strep A+ FIA, Sofia 2 Analyzer (K171976)Quidel Corporation2017-12-21
Sofia Lyme FIA, Sofia Lyme Control Set (K163713)Quidel Corporation2017-10-20
Solana RSV+hMPV Assay (K171974)Quidel Corporation2017-10-16
Solana C. difficile Assay (K170491)Quidel Corporation2017-05-11
Sofia Influenza A+B FIA on Sofia 2 (K162438)Quidel Corporation2017-04-14
Sofia RSV FIA on Sofia 2 analyzer (K162911)Quidel Corporation2017-02-22
Solana HSV 1+2/VZV Assay (K162451)Quidel Corporation2016-11-28
Solana Strep Complete Assay (K162274)Quidel Corporation2016-10-25
Solana Influenza A+B Assay (K161814)Quidel Corporation2016-09-27
Solana Trichomonas Assay (K161182)Quidel Corporation2016-08-15
Sofia Influenza A+B FIA (K153012)Quidel Corporation2016-01-12
Solana GAS Assay, Solana instrument (K150868)Quidel Corporation2015-06-23
AmpliVue Trichomonas Assay (K143329)Quidel Corporation2015-03-17
SOFIA (R) STREP A+ FIA (K141775)Quidel Corporation2014-12-16
AmpliVue Bordetella Assay (K143206)Quidel Corporation2014-12-10
LYRA PARAINFLUENZA VIRUS ASSAY (K141927)Quidel Corporation2014-10-09
LYRA ADENOVIRUS ASSAY (K141931)Quidel Corporation2014-10-09
AMPLIVUE GAS ASSAY (K141173)Quidel Corporation2014-07-24
LYRA DIRECT STREP ASSAY (DEN140005)Quidel Corporation2014-04-16
AMIPLIVUE HSV 1&2 ASSAY (K140029)Quidel Corporation2014-03-26
AMPLIVUE GBS ASSAY (K133503)Quidel Corporation2013-12-20
QUICK VUE INFLUENZA (K131599)Quidel Corporation2013-07-05
SOFIA STREP A FIA (K123793)Quidel Corporation2013-06-17
AMPLIVUE C. DIFFICILE ASSAY (K123355)Quidel Corporation2012-12-13
RAPIDVUE HCG TEST (K102175)Quidel Corporation2010-08-25

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Every clearance here is in the API, with alerts when new ones post.