Panels › Microbiology › Product code QOF · Class 2
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Regulation 866.3981
9510(k)s in 12 months (38 all time)
3recalls in 12 months (9 all time)
4recalls that name a 510(k)
Top companies in QOF
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics | 7 | 6 |
| Cepheid | 7 | 0 |
| Hologic, Inc. | 3 | 1 |
| Roche Molecular Systems, Inc. | 4 | 0 |
| Diasorin Molecular, LLC | 3 | 0 |
| QIAGEN GmbH | 3 | 0 |
| Baebies, Inc. | 2 | 0 |
| Nuclein, LLC | 1 | 1 |
| Abbott Molecular, Inc. | 1 | 0 |
| Autonomous Medical Devices Incorporated | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K263333 | Xpert Xpress CoV-2/Flu plus Cepheid® | QOF |
| Oct 2, 2026 | K263120 | Xpert Xpress CoV-2/Flu plus Cepheid® | QOF |
| Sep 25, 2026 | K261336 | Xpert Respiratory Panel Cepheid | QOF |
| Sep 22, 2026 | K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics | QOF |
| Sep 11, 2026 | K261837 | FINDER Flu A&B/SARS-CoV-2 Test Baebies, Inc. | QOF |
| Jun 12, 2026 | K252932 | Fast PCR Mini Respiratory Panel Autonomous Medical Devices Incorporated | QOF |
| Mar 30, 2026 | K252269 | FINDER Flu A&B/SARS-CoV-2 Test Baebies, Inc. | QOF |
| Feb 13, 2026 | K251742 | VELO Respiratory Test Lex Diagnostics Limited, GB | QOF |
| Dec 23, 2025 | K251978 | LIAISON NES FLU A/B, RSV & COVID-19 Diasorin Molecular, LLC | QOF |
| Oct 30, 2025 | K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) Diasorin Molecular, LLC | QOF |
| Aug 27, 2025 | K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini QIAGEN GmbH, DE | QOF |
| Aug 14, 2025 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini Biofire Diagnostics, LLC | QOF |
| Jul 31, 2025 | K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems Roche Molecular Systems, Inc. | QOF |
| May 1, 2025 | K250996 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid® | QOF |
| May 1, 2025 | K250995 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid® | QOF |
| Apr 25, 2025 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test Roche Molecular Systems, Inc. | QOF |
| Apr 25, 2025 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test Roche Molecular Systems, Inc. | QOF |
| Feb 19, 2025 | K242526 | Visby Medical Respiratory Health Test Visby Medical, Inc. | QOF |
| Feb 14, 2025 | K241573 | Alinity m Resp-4-Plex Abbott Molecular, Inc. | QOF |
| Jan 10, 2025 | K242071 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid | QOF |
| Jan 8, 2025 | K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel Life Technologies Corporation | QOF |
| Dec 20, 2024 | K241652 | DASH® SARS-CoV-2 & Flu A/B Test Nuclein, LLC | QOF |
| Nov 15, 2024 | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay Hologic, Inc. | QOF |
| Oct 25, 2024 | K242353 | QIAstat-Dx Respiratory Panel Mini QIAGEN GmbH, DE | QOF |
| Jul 18, 2024 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Hologic, Inc. | QOF |
| May 30, 2024 | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini Biofire Diagnostics, LLC | QOF |
| May 10, 2024 | K233100 | QIAstat-Dx® Respiratory Panel Plus QIAGEN GmbH, DE | QOF |
| Mar 26, 2024 | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Biofire Diagnostics, LLC | QOF |
| Mar 11, 2024 | K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) Luminex Molecular Diagnostics, Inc., CA | QOF |
| Mar 1, 2024 | K233410 | LIAISON PLEX Respiratory Flex Assay Luminex Corporation | QOF |
| Aug 17, 2023 | K231481 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid® | QOF |
| Jul 31, 2023 | K230956 | BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System Bd Integrated Diagnostic Solutions / | QOF |
| Jul 27, 2023 | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System Roche Molecular Systems, Inc. | QOF |
| May 16, 2023 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Hologic, Inc. | QOF |
| Apr 13, 2023 | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini Biofire Diagnostics, LLC | QOF |
| Mar 17, 2023 | K220963 | Simplexa COVID-19 & Flu A/B Direct Diasorin Molecular, LLC | QOF |
| Feb 3, 2023 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel Biofire Diagnostics | QOF |
| Mar 17, 2021 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC | QOF |
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