QuidelOrtho Wins FDA Clearance for VITROS High-Sensitivity Troponin I Assay

Reuters

2025/11/03

QuidelOrtho Wins FDA Clearance for VITROS High-Sensitivity Troponin I Assay

QuidelOrtho Corporation has received FDA 510(k) clearance for its VITROS hs Troponin I Assay, designed for the quantitative measurement of cardiac troponin I in human plasma to aid in the diagnosis of myocardial infarction. This high-sensitivity assay enables faster and more accurate identification of heart attacks, supporting timely clinical decision-making and improved patient outcomes. The clearance expands the diagnostic menu available on VITROS Systems, with commercial rollout for U.S. laboratories expected to begin later this year. The approval is specific to QuidelOrtho Corporation.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quidelortho Corporation published the original content used to generate this news brief via PR Newswire (Ref. ID: LA12826) on November 03, 2025, and is solely responsible for the information contained therein.

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ID: LA12826) on November 03, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4082","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251103:nNDLb6rBy2:1","article_id":"2580297524","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2580297524","pubTimestamp":1762171298,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"QuidelOrtho Corporation has received FDA 510 clearance for its VITROS hs Troponin I Assay, designed for the quantitative measurement of cardiac troponin I in human plasma to aid in the diagnosis of myocardial infarction. 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