CO-DIAGNOSTICS DL-,001 WKN: A2DU6V ISIN: US1897631057 Kürzel: CODX Forum: Aktien Thema: Hauptdiskussion
SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) clearance. Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument. The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.
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| 1 | Trading- und Aktien-Chat | ||
| 2 | für alle, die es ehrlich meinen beim Traden. | ||
| 3 | Mercedes-Benz Group Hauptdiskussion | +0,83 % | |
| 4 | VONOVIA Hauptdiskussion | +2,42 % | |
| 5 | Aktien und Saunaclub alla Luci | ||
| 6 | Circus SE Inhaber-Akt Hauptdiskussion | -6,65 % | |
| 7 | Security der nächsten Generation | -2,10 % | |
| 8 | Ecograf - ein Stern am Graphithimmel | +6,03 % | |
| 9 | Critical Infrastructure Technologies Hauptdiskussion | -5,05 % | |
| 10 | Canopy Hauptforum | +53,98 % | Alle Diskussionen |
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| 1 | Mercedes-Benz Group Hauptdiskussion | +0,83 % | |
| 2 | VONOVIA Hauptdiskussion | +2,42 % | |
| 3 | Circus SE Inhaber-Akt Hauptdiskussion | -6,65 % | |
| 4 | Security der nächsten Generation | -2,10 % | |
| 5 | MONUMENT MINING Hauptdiskussion | +6,75 % | |
| 6 | Renk Group | -2,50 % | |
| 7 | The Cannabist (Hauptforum) | +89,68 % | |
| 8 | Canopy Hauptforum | +52,86 % | |
| 9 | Critical Infrastructure Technologies Hauptdiskussion | -5,05 % | |
| 10 | Ecograf - ein Stern am Graphithimmel | +6,03 % | Alle Diskussionen |