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Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance

Summary by The Chandler Arizonan
The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component

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The Chandler ArizonanThe Chandler Arizonan
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Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance

The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component

·Chandler, United States
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wkrb13.comwkrb13.com

Co-Diagnostics Inc. to Submit Enhanced COVID-19 Test for FDA 510(k) Clearance

In a move towards improving its diagnostic offerings, Utah-based molecular diagnostics firm Co-Diagnostics Inc. has announced its decision to submit an improved version of its COVID-19 test for 510(k) clearance to the U.S. Food and Drug Administration (FDA). The company made this decision following an interactive dialogue with the regulatory body and in light of […]

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IT News DirectIT News Direct

Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance - IT News Direct

The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component 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 Admin…

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The Chandler Arizonan broke the news in Chandler, United States on Friday, February 21, 2025.
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