FDA 510(k) Applications for Medical Device Product Code "QOF"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K241573 | Abbott Molecular Inc | Alinity m Resp-4-Plex | 02/14/2025 |
| K230956 | BD Integrated Diagnostic Solutions/ | BD Respiratory Viral Panel for BD MAXÖ System; BD Respiratory Viral Panel-SCV2 for BD MAXÖ System | 07/31/2023 |
| K213954 | BioFire Diagnostics | BIOFIRE SPOTFIRE Respiratory (R) Panel | 02/03/2023 |
| DEN200031 | Biofire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) | 03/17/2021 |
| K232954 | BioFire Diagnostics, LLC | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | 03/26/2024 |
| K241194 | BioFire Diagnostics, LLC | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | 05/30/2024 |
| K230719 | Biofire Diagnostics, LLC | BIOFIRE« SPOTFIRE« Respiratory (R) Panel Mini | 04/13/2023 |
| K242071 | Cepheid | Xpert Xpress CoV-2/Flu/RSV plus | 01/10/2025 |
| K250995 | Cepheid« | Xpert Xpress CoV-2/Flu/RSV plus | 05/01/2025 |
| K231481 | Cepheid« | Xpert Xpress CoV-2/Flu/RSV plus | 08/17/2023 |
| K250996 | Cepheid« | Xpert Xpress CoV-2/Flu/RSV plus | 05/01/2025 |
| K220963 | DiaSorin Molecular LLC | Simplexa COVID-19 & Flu A/B Direct | 03/17/2023 |
| K241240 | Hologic, Inc. | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | 07/18/2024 |
| K242465 | Hologic, Inc. | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | 11/15/2024 |
| K222736 | Hologic, Inc. | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | 05/16/2023 |
| K241806 | Life Technologies Corporation | Applied BiosystemsÖ TaqPathÖ COVID-19, Flu A, Flu B, RSV Select Panel | 01/08/2025 |
| K233410 | Luminex Corporation | LIAISON PLEX Respiratory Flex Assay | 03/01/2024 |
| K231758 | Luminex Molecular Diagnostics, Inc. | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | 03/11/2024 |
| K241652 | Nuclein, LLC | DASH« SARS-CoV-2 & Flu A/B Test | 12/20/2024 |
| K242353 | Qiagen GmbH | QIAstat-Dx Respiratory Panel Mini | 10/25/2024 |
| K233100 | QIAGEN GmbH | QIAstat-Dx« Respiratory Panel Plus | 05/10/2024 |
| K243400 | Roche Molecular Systems, Inc. | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | 04/25/2025 |
| K243406 | Roche Molecular Systems, Inc. | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | 04/25/2025 |
| K223591 | Roche Molecular Systems, Inc. | cobas« SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas« Liat« System | 07/27/2023 |
| K242526 | Visby Medical, Inc. | Visby Medical Respiratory Health Test | 02/19/2025 |
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