Panels › Microbiology › Product code QQX · Class 2
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Regulation 866.3981
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QQX
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 3 | 0 |
| Biofire Defense, LLC | 2 | 0 |
| Cepheid® | 2 | 0 |
| Abbott Molecular | 1 | 0 |
| Diasorin Molecular, LLC | 1 | 0 |
| Hologic, Inc. | 1 | 0 |
| Life Technologies Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2025 | K243396 | Aptima SARS-CoV-2 Assay Hologic, Inc. | QQX |
| Feb 11, 2025 | K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems Roche Molecular Systems, Inc. | QQX |
| Jan 15, 2025 | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) Cepheid® | QQX |
| Dec 6, 2024 | K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) Abbott Molecular | QQX |
| Jul 10, 2024 | K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit Life Technologies Corporation | QQX |
| Oct 13, 2023 | K230440 | Xpert® Xpress CoV-2 plus Cepheid® | QQX |
| Jun 1, 2023 | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems Roche Molecular Systems, Inc. | QQX |
| Oct 22, 2022 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems Roche Molecular Systems, Inc. | QQX |
| Sep 13, 2022 | K212147 | Simplexa COVID-19 Direct Diasorin Molecular, LLC | QQX |
| Jul 25, 2022 | K221460 | BioFire COVID-19 Test 2 Biofire Defense, LLC | QQX |
| Nov 1, 2021 | K211079 | BioFire COVID-19 Test 2 Biofire Defense, LLC | QQX |
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