FDA-Device2021-07-14Class II
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
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
17,110
Manufactured in
4088 Commercial Ave, Northbrook, IL, United States
Products
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2008-2021Don't want to check this manually?
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