(RTTNews) – Qiagen ( QGEN ) has granted US regulatory approval for the first in a suite of QIAstat-Dx Gastrointestinal Panel assessments for scientific stuttering.
FDA approval marks the 2nd mini syndrome panel in the US and is available for use with QIAstat-Dx programs.
The removal includes the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial and Viral), which maintains the five causes of gastrointestinal disease promoted by the Infectious Diseases Society of America (IDSA): Campylobacter, Salmonella, Shigi-like toxin E.Coli (STEC), and Shigella, along with norovirus, is one of the most common causes of gastrointestinal infections and an important target for the length of the winter season.
A second model of the Gastrointestinal Panel, which maintains the five primary bacterial pathogens that cause gastrointestinal infections (Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica), will apparently be submitted to the FDA for approval in the coming weeks.
QIAGEN also plans to have QIAstat-Dx Upward thrust, a model of a smarter diagnostic instrument capability, approved by the FDA in early 2025.
The company is known to provide comprehensive verification of up to 160 assessments per day, using eight analytical modules in lieu of 4. QIAstat-Dx syndromic verification with cloud connectivity and epidemiological insights is available in more than 100 countries. , with more than 4,000 devices worldwide.
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