Product code QLT ยท Class N
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
0510(k)s in 12 months (0 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in QLT
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 0 | 4 |
| Qiagen Sciences LLC | 0 | 3 |
| Qiagen GmbH | 0 | 2 |
| Luminex Molecular Diagnostics Inc | 0 | 1 |
| NeuMoDx Molecular Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2024 | Luminex Molecular Diagnostics Inc NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 Open, Classified |
QLT | None listed |
| Jul 27, 2023 | Qiagen GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.)
Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of resp Open, Classified |
QLT | None listed |
| Jul 27, 2023 | Qiagen GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or Open, Classified |
QLT | None listed |
| Jun 2, 2023 | Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 Open, Classified |
QLT | None listed |
| Feb 7, 2023 | Roche Molecular Systems, Inc. cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190 Open, Classified |
QLT | None listed |
| Feb 7, 2023 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190 Open, Classified |
QLT | None listed |
| Feb 7, 2023 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190 Open, Classified |
QLT | None listed |
| May 13, 2022 | NeuMoDx Molecular Inc NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 Open, Classified |
QLT | None listed |
| Nov 8, 2021 | Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 Terminated |
QLT | None listed |
| Aug 4, 2021 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 Terminated |
QLT | None listed |
| Jul 15, 2020 | Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral an Terminated |
QLT | None listed |
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