Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list LumiQuick Diagnostics with 80 device recalls and 1 510(k) clearance. The most recent is a device recall dated Mar 4, 2014: Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054.
| Mar 4, 2014 | Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | Cocaine Test Card; LumiQuick. Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | EDDP Test Card; LumiQuick. Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | Barbiturate Strip; LumiQuick. Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Mar 4, 2014 | Ketamine Strip; LumiQuick,. Santa Clara, CA 95054Class II · Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Device recalls |
| Oct 18, 2013 | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICEK130213 · LDJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
