FDA-Device2014-04-16Class II
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Hazard
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Sold states
Distributed in the states of CA, FL, NJ, TX, and NY.
Affected count
ALL
Manufactured in
2946 Scott Blvd, N/A, Santa Clara, CA, United States
Products
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2014Don't want to check this manually?
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