Fujirebio Diagnostics has submitted a premarket notification — also known as a 510(k) — to the U.S. Food and Drug Administration (FDA) for its Alzheimer’s diagnostic test, called Lumipulse G β-Amyloid Ratio (1-42/1-40). If cleared by the FDA, it will be among the first commercially available lab tests to assess the risk of Alzheimer’s disease in adults with signs of cognitive impairment. The new Lumipulse G β [beta]-Amyloid ratio combines two individual tests, the Lumipulse G…
You must be logged in to read/download the full post.
The post Fujirebio Seeks FDA’s Premarket Approval for Diagnostic Test appeared first on BioNewsFeeds.