Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform [Yahoo! Finance]
Co-Diagnostics, Inc. (CODX)
US:NASDAQ Investor Relations:
ir.codiagnostics.com/investor-relations
Company Research
Source: Yahoo! Finance
SALT LAKE CITY June 14, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: 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 the Company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use. Co-Diagnostics completed the submission via the FDA's electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation. The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralizati
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News
- Co-Diagnostics, Inc. to Participate at FIME 2024 in Miami Beach, June 19-21 [Yahoo! Finance]Yahoo! Finance
- Co-Diagnostics, Inc. to Participate at FIME 2024 in Miami Beach, June 19-21PR Newswire
- Co-Diagnostics, Inc. (NASDAQ: CODX) had its "neutral" rating re-affirmed by analysts at HC Wainwright. They now have a $2.00 price target on the stock.MarketBeat
- Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro PlatformPR Newswire
- Digital Pathology Market size is set to grow by USD 1.12 billion from 2024-2028, Growing adoption of iot infrastructure among laboratories to boost the market growth, Technavio [Yahoo! Finance]Yahoo! Finance
CODX
Earnings
- 5/9/24 - Miss
CODX
Analyst Actions
- 6/17/24 - HC Wainwright
CODX
Sec Filings
- 6/14/24 - Form 8-K
- 5/28/24 - Form 4
- 5/28/24 - Form 4
- CODX's page on the SEC website