FDA 510(k) Applications for Medical Device Product Code "QQX"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K241580 | Abbott Molecular | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | 12/06/2024 |
| K211079 | BioFire Defense, LLC | BioFire COVID-19 Test 2 | 11/01/2021 |
| K221460 | BioFire Defense, LLC | BioFire COVID-19 Test 2 | 07/25/2022 |
| K230440 | Cepheid« | Xpert« Xpress CoV-2 plus | 10/13/2023 |
| K242109 | Cepheid« | Xpert« Xpress CoV-2 plus (XPRS-COV2-10) | 01/15/2025 |
| K212147 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct | 09/13/2022 |
| K243396 | Hologic, Inc. | Aptima SARS-CoV-2 Assay | 02/13/2025 |
| K233453 | Life Technologies Corporation | Applied BiosystemsÖ TaqPathÖ COVID-19 Diagnostic PCR Kit | 07/10/2024 |
| K231306 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | 06/01/2023 |
| K213804 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | 10/22/2022 |
| K240867 | Roche Molecular Systems, Inc. | cobas« SARS-CoV-2 Qualitative for use on the cobas« 5800/6800/8800 Systems | 02/11/2025 |
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