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InBios News

FDA Clearance

April 08, 2011
FDA announces InBios' DENV DetectTM IgM Capture ELISA is the first cleared to market to help diagnose dengue virus infection.

FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250584.htm

Other links:

http://firstwatch.jwatch.org/cgi/content/full/2011/411/3

 

ISO Certified

August 18, 2010

 InBios is ISO 13485:2003 certified.

510(k) Clearance

November 19, 2004

InBios has received 510(k) clearance from the Food and Drug Administration for its West Nile Detect IgM Capture ELISA. This in vitro diagnostic assay is highly sensitive and specific for the West Nile Virus. This kit is available worldwide.

510(k) Clearance

May 26, 2003

InBios has received 510(k) clearance from the Food and Drug Administration for its Kalazar Detect Rapid Test. This kit is available worldwide.