FDA-Device2023-04-19Class III
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
AGILENT TECHNOLOGIES INC./US
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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