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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 1 of 3

Device	Model / Reference	Registries	Class	Status
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-06	FDA UDI	Class II	Active
QuickProfile™ 2019-nCoV IgG/IgM Antibody Test	71108B	FDA UDI	N	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-31	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7204-04	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-42	FDA UDI	Class II	Active
QuickProfile™ Amphetamine Test Card	07RD7014	FDA UDI	Class II	Active
QuickProfile™ Cocaine Test Card	07RD7008	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 9 Test	07RD7072-01	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-39	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 4 Test	07RD7063-01	FDA UDI	Class II	Active
QuickProfile™ Amphetamine Test Card	74014	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-03	FDA UDI	Class II	Active
QuickProfile™ Benzodiazepine Test Strip	07RD7017	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 4 Test	07RD7063-03	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-40	FDA UDI	Class II	Active
QuickProfile™ Buprenorphine Test Card	07RD7106	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7116-09	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 4 Test	07RD7063-28	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7116-04	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7207-14	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7113-03	FDA UDI	Class II	Active
QuickProfile™ THC Test Card	07RD7010	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-11	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7108-01	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-14	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-05	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7210-06	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-23	FDA UDI	Class II	Active
QuickProfile™ Amphetamine Test Strip	07RD7013	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 8 Test	07RD7071-20	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7210-03	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-28	FDA UDI	Class II	Active
Rapid SARS-CoV-2 Antigen Test Card	1N40C5-1-US-BS	FDA UDI	N	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-04	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7207-10	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7111-03	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7210-05	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 10 Test	07RD7073-08	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 5 Test	07RD7064-34	FDA UDI	Class II	Active
QuickProfile™ Barbiturate Test Strip	07RD7015	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7206-12	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7207-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 7 Test	07RD7070-13	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 6 Test	07RD7065-32	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Panel 9 Test	07RD7072-10	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Panel 2 Test	07RD7061-02A	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7205-09	FDA UDI	U	Active
QuickProfile™ PCP Test Strip	07RD7021	FDA UDI	U	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7111-02	FDA UDI	Class II	Active
QuickProfile™ Drugs of Abuse Test Cup	07RD7206-09	FDA UDI	Class II	Active

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Importers

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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.