FDA-Device2025-01-22Class II
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Accriva Diagnostics, Inc.
Hazard
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Sold states
US Nationwide distribution in the state of VA.
Affected count
25
Manufactured in
6260 Sequence Dr, San Diego, CA, United States
Products
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2025Don't want to check this manually?
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