| Z-2545-2025 | Class II | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC | June 17, 2025 |
| Z-1637-2024 | Class II | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests | March 5, 2024 |
| Z-1636-2024 | Class II | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests | March 5, 2024 |
| Z-1086-2024 | Class II | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that i | January 3, 2024 |
| Z-1308-2023 | Class II | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human | February 1, 2023 |
| Z-2477-2021 | Class II | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 | August 13, 2021 |
| Z-1928-2021 | Class I | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | April 27, 2021 |
| Z-0428-2021 | Class II | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | September 25, 2020 |
| Z-0124-2021 | Class II | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluores | September 17, 2020 |
| Z-1183-2018 | Class II | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with | December 15, 2017 |
| Z-2803-2017 | Class II | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay | June 22, 2017 |
| Z-1231-2017 | Class II | Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package conta | January 25, 2017 |
| Z-0819-2013 | Class II | Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. | December 3, 2012 |