FDA-Device2021-07-14Class II
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Luminex Corporation
Hazard
Potential for a false-negative result.
Sold states
Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
Affected count
24,338
Manufactured in
4088 Commercial Ave, Northbrook, IL, United States
Products
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2009-2021Don't want to check this manually?
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