FDA-Device2018-11-21Class II
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
Luminex Corporation
Hazard
Potential to lead to a false negative results.
Sold states
Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France
Affected count
12,700 trays
Manufactured in
12212 Technology Blvd, Austin, TX, United States
Products
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0445-2019Don't want to check this manually?
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