FDA-Device2014-04-16Class II
Tuberculosis Antibody Test Card Serum; 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
Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1356-2014Don't want to check this manually?
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