Devices descending from K211079
11 later devices reach BioFire COVID-19 Test 2 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | 2025 | 0 | — |
| +1 | K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | Life Technologies Corporation | 2024 | 0 | — |
| +1 | K230440 | Xpert® Xpress CoV-2 plus | Cepheid® | 2023 | 1 | — |
| +1 | K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD… | Bd Integrated Diagnostic Solutions / | 2023 | 0 | — |
| +1 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2022 | 3 | — |
| +1 | K212147 | Simplexa COVID-19 Direct | Diasorin Molecular, LLC | 2022 | 0 | — |
| +1 | K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022 | 1 | — |
| +2 | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® | 2025 | 0 | — |
| +2 | K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Abbott Molecular | 2024 | 0 | — |
| +2 | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2023 | 1 | — |
| +3 | K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025 | 0 | — |