FDA-Device2023-04-19Class III
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Hazard
Distributed sample collection kit with an unapproved instruction for use.
Sold states
U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
Affected count
560 kits
Manufactured in
550 Kirkland Way, Suite, N/A, Kirkland, WA, United States
Products
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2023Don't want to check this manually?
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