| K171976 |
06/30/2017 |
Sofia Strep A+ FIA, Sofia 2 Analyzer |
Quidel Corporation |
| K153012 |
10/14/2015 |
Sofia Influenza A+B FIA |
QUIDEL CORPORATION |
| K162911 |
10/17/2016 |
Sofia RSV FIA on Sofia 2 analyzer |
Quidel Corporation |
| K163713 |
12/30/2016 |
Sofia Lyme FIA, Sofia Lyme Control Set |
Quidel Corporation |
| K180288 |
02/01/2018 |
QuickVue Influenza A+B |
Quidel Corporation |
| K162438 |
08/31/2016 |
Sofia Influenza A+B FIA on Sofia 2 |
Quidel Corporation |
| K173496 |
11/13/2017 |
Sofia 2 Lyme FIA, Sofia Lyme Control Set |
Quidel Corporation |
| K173691 |
12/01/2017 |
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack |
Quidel Corporation |
| K141775 |
07/01/2014 |
SOFIA (R) STREP A+ FIA |
QUIDEL CORPORATION |
| K131599 |
06/03/2013 |
QUICK VUE INFLUENZA |
QUIDEL CORPORATION |
| K123793 |
12/10/2012 |
SOFIA STREP A FIA |
QUIDEL CORPORATION |
| K211342 |
05/03/2021 |
Sofia 2 Campylobacter FIA |
Quidel Corporation |
| K102175 |
08/02/2010 |
RAPIDVUE HCG TEST |
QUIDEL CORPORATION |
| K232286 |
08/01/2023 |
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument |
Quidel Corporation |
| K140029 |
01/06/2014 |
AMIPLIVUE HSV 1&2 ASSAY |
QUIDEL CORPORATION |
| DEN140005 |
03/25/2014 |
LYRA DIRECT STREP ASSAY |
QUIDEL CORPORATION |
| K150868 |
04/01/2015 |
Solana GAS Assay, Solana instrument |
QUIDEL CORPORATION |
| K161182 |
04/27/2016 |
Solana Trichomonas Assay |
QUIDEL CORPORATION |
| K141173 |
05/06/2014 |
AMPLIVUE GAS ASSAY |
QUIDEL CORPORATION |
| K141927 |
07/16/2014 |
LYRA PARAINFLUENZA VIRUS ASSAY |
QUIDEL CORPORATION |
| K141931 |
07/16/2014 |
LYRA ADENOVIRUS ASSAY |
QUIDEL CORPORATION |
| K162274 |
08/12/2016 |
Solana Strep Complete Assay |
Quidel Corporation |
| K123355 |
10/31/2012 |
AMPLIVUE C. DIFFICILE ASSAY |
QUIDEL CORPORATION |
| K133503 |
11/14/2013 |
AMPLIVUE GBS ASSAY |
QUIDEL CORPORATION |
| K143329 |
11/20/2014 |
AmpliVue Trichomonas Assay |
QUIDEL CORPORATION |
| K170491 |
02/17/2017 |
Solana C. difficile Assay |
Quidel Corporation |
| K181029 |
04/18/2018 |
Solana Bordetella Complete Assay |
Quidel Corporation |
| K171974 |
06/30/2017 |
Solana RSV+hMPV Assay |
Quidel Corporation |
| K161814 |
07/01/2016 |
Solana Influenza A+B Assay |
Quidel Corporation |
| K162451 |
09/01/2016 |
Solana HSV 1+2/VZV Assay |
QUIDEL CORPORATION |
| K173250 |
10/10/2017 |
Solana GBS Assay |
Quidel Corporation |
| K143206 |
11/07/2014 |
AmpliVue Bordetella Assay |
QUIDEL CORPORATION |
| K230236 |
01/30/2023 |
Lyra Influenza A+B Assay |
Quidel Corporation |
| K230349 |
02/09/2023 |
Lyra RSV+hMPV Assay |
Quidel Corporation |
| K231795 |
06/20/2023 |
QuickVue COVID-19 Test |
Quidel Corporation |
| DEN220039 |
06/16/2022 |
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set |
Quidel Corporation |
| K233688 |
11/17/2023 |
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set |
Quidel Corporation |
