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LumiQuick Diagnostics, Inc.

Last updated September 17, 2026

About

Diagnostics products for In vitro testing , forensic and/or research use. Rapid Tests, POCT, EIA, PCR

From the manufacturer's own website. Source

Information

Country: US
Address: 2946 SCOTT BLVD., SANTA CLARA, CA, 95054
Website: www.lumiquick.com
LinkedIn: linkedin.com/company/17983392
Facebook: facebook.com/lumiquickdiagnostics
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005984081
DUNS Number: —

Catalogue (136)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
QuickProfile™ Benzodiazepine Test Card	07RD7018	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7113-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7113-05	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 2 Test	07RD7061-03	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 3 Test	07RD7062-04	FDA UDI	Class II	Active
QuickProfile™ HCG Test Card	W1-C	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-01	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 8 Test	07RD7071-12	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7210-11	FDA UDI	Class II	Active
QuickProfile™ Opiate Test Card	07RD7012	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test Card	07RD7184-02A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-03A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 2 Test	07RD7061-04A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-18	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7111-04	FDA UDI	Class II	Active
QuickProfile™ Methamphetamine Test Card	07RD7006	FDA UDI	Class II	Active
QuickProfile™ Oxycodone Test Card	07RD7101	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7205-01	FDA UDI	Class II	Active
QuickProfile™ Methamphetamine Test Strip	07RD7005	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7116-08	FDA UDI	Class II	Active
QuickProfile™ Covid-19/FluA&B Antigen Combo Test	71118-1T	FDA UDI	N	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-01A	FDA UDI	Class II	Active
QuickProfile™ THC Test Strip	07RD7009	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-01	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-40	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-02	FDA UDI	Class II	Active
QuickProfile™ Opiate Test Strip	07RD7011	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-15	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 2 Test	07RD7061-01	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-34A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7205-07	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7206-05	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7116-13	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7112-15	FDA UDI	Class II	Active
QuickProfile™ Methadone Test Strip	07RD7019	FDA UDI	Class II	Active
Quickprofile Single Drug Of Abuse Device And Quick Profile Multi-Drugs Of Abuse Screen Device	K130213	FDA 510(k)	Class II	Active

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (80)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 4, 2014	Z-1413-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1348-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1381-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1366-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1354-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1387-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1359-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1409-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1393-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1356-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1358-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1416-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1346-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1378-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1350-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1379-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1410-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1344-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1380-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1342-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1412-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1375-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1363-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1364-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1383-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1386-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1388-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1352-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1401-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1396-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1369-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1361-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1390-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1347-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1368-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1357-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1404-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1377-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1397-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1337-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1340-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1399-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1345-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1355-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1406-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1391-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1389-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1349-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1403-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1376-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1351-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1400-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1341-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1362-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1405-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1385-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1415-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1370-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1402-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1373-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1372-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1407-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1398-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1395-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1414-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1343-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1353-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1382-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1411-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1338-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1360-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1408-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1384-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1392-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1394-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1374-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1339-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1365-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1367-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Mar 4, 2014	Z-1371-2014	—	terminated	Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.