FDA-Device2021-07-14Class II
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
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
1,261
Manufactured in
4088 Commercial Ave, Northbrook, IL, United States
Products
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2010-2021Don't want to check this manually?
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