LumiQuick Diagnostics Inc.

FDA Regulatory Profile

Summary

Total Recalls
80
510(k) Clearances
1
Inspections
5
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1396-2014Class IIOxycodone Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1394-2014Class IIBuprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1412-2014Class IICardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1406-2014Class IIClonazepam Test Card; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1384-2014Class IIMorphine Strip (300); LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1386-2014Class IIMorphine Strips (2000); LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1369-2014Class IIAmphetamine Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1370-2014Class IIBarbiturate Strip; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1357-2014Class IIMalaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1338-2014Class IISyphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1349-2014Class IIStrep A Test Card; LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1359-2014Class IIDengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1343-2014Class IISalmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1344-2014Class IIRotavirus Test Card LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1377-2014Class IIEDDP Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1385-2014Class IIMorphine Test Card (300); LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1371-2014Class IIBarbiturate Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1390-2014Class IITHC Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1366-2014Class IITramadol Strip; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1408-2014Class IIK2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054March 4, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICEOctober 18, 2013