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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 2 of 3

Device	Model / Reference	Registries	Class	Status
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-22	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7205-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-04	FDA UDI	U	Active
QuickProfile™ PCP Test Card	07RD7022	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Test Cup	74046-II	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7210-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7206-01	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7210-05A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7207-16	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7112-13	FDA UDI	Class II	Active
QuickProfile™ Buprenorphine Test Strip	07RD7105	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7208-11	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7113-06	FDA UDI	Class II	Active
QuickProfile™ Barbiturate Test Card	07RD7016	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-15	FDA UDI	Class II	Active
QuickProfile™ Oxycodone Test Strip	07RD7100	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7206-11	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-43	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7110-22	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-39	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-03	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7205-10	FDA UDI	Class II	Active
QuickProfile™ Methadone Test Card	07RD7020	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7112-12	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7111-01	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7108-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-15	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-04	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7207-17	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7205-08	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7112-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-19	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-17	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7113-04	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7116-01	FDA UDI	Class II	Active
QuickProfile™ HCG Test Strip	07RD7001	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-09	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7116-03	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-14	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 4 Test	07RD7063-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-01	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-12	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 3 Test	07RD7062-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7111-31	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7211-01	FDA UDI	Class II	Active
QuickProfile™ Cocaine Test Strip	07RD7007	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7110-21	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 3 Test Card	07RD7093-11A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7208-10	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

Not available yet.

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.