Devices descending from DEN200031
46 later devices reach BioFire Respiratory Panel 2.1 (RP2.1) through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | 2026 | 0 | — |
| +1 | K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025 | 0 | — |
| +1 | K241806 | Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | Life Technologies Corporation | 2025 | 0 | — |
| +1 | K233100 | QIAstat-Dx® Respiratory Panel Plus | QIAGEN GmbH | 2024 | 3 | 1 |
| +1 | K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics, Inc. | 2024 | 0 | — |
| +1 | K233410 | LIAISON PLEX Respiratory Flex Assay | Luminex Corporation | 2024 | 0 | — |
| +1 | K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2023 | 4 | — |
| +1 | K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD… | Bd Integrated Diagnostic Solutions / | 2023 | 0 | — |
| +1 | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | Roche Molecular Systems, Inc. | 2023 | 1 | — |
| +1 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023 | 6 | 1 |
| +1 | K220963 | Simplexa COVID-19 & Flu A/B Direct | Diasorin Molecular, LLC | 2023 | 3 | — |
| +1 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023 | 6 | — |
| +1 | K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021 | 11 | — |
| +2 | K261336 | Xpert Respiratory Panel | Cepheid | 2026 | 0 | — |
| +2 | K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026 | 1 | — |
| +2 | K251742 | VELO Respiratory Test | Lex Diagnostics Limited | 2026 | 0 | — |
| +2 | K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH | 2025 | 0 | — |
| +2 | K250996 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2025 | 0 | — |
| +2 | K242526 | Visby Medical Respiratory Health Test | Visby Medical, Inc. | 2025 | 0 | — |
| +2 | K241573 | Alinity m Resp-4-Plex | Abbott Molecular, Inc. | 2025 | 0 | — |
| +2 | K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | 2025 | 0 | — |
| +2 | K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | 2025 | 2 | — |
| +2 | K242353 | QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH | 2024 | 1 | — |
| +2 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024 | 4 | — |
| +2 | K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | Life Technologies Corporation | 2024 | 0 | — |
| +2 | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024 | 2 | 1 |
| +2 | K230440 | Xpert® Xpress CoV-2 plus | Cepheid® | 2023 | 1 | — |
| +2 | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Biofire Diagnostics, LLC | 2023 | 2 | — |
| +2 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2022 | 3 | — |
| +2 | K212147 | Simplexa COVID-19 Direct | Diasorin Molecular, LLC | 2022 | 0 | — |
| +2 | K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022 | 1 | — |
| +3 | K261837 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026 | 0 | — |
| +3 | K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | 2026 | 0 | — |
| +3 | K251978 | Liaison Nes Flu a/B, RSV & Covid-19 | Diasorin Molecular, LLC | 2025 | 0 | — |
| +3 | K250995 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2025 | 0 | — |
| +3 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025 | 0 | — |
| +3 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. | 2025 | 0 | — |
| +3 | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® | 2025 | 0 | — |
| +3 | K241652 | DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC | 2024 | 0 | 3 |
| +3 | K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Abbott Molecular | 2024 | 0 | — |
| +3 | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. | 2024 | 1 | — |
| +3 | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC | 2024 | 1 | — |
| +3 | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2023 | 1 | — |
| +4 | K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV… | Diasorin Molecular, LLC | 2025 | 0 | — |
| +4 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025 | 0 | — |
| +4 | K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025 | 0 | — |