MedtechSourcebook

LUMIQUICK DIAGNOSTICS, INC.

Contract manufacturer ยท Santa Clara, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2019Product codes first listed, by year (tallest: 1)2026
FDA registration
3005984081 (openFDA record; or search FDA's registration database)
FEI number
3005984081
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler; Single-use device reprocessor
Owner or operator
LUMIQUICK DIAGNOSTICS, INC. (FDA owner/operator no. 9093981)
Registered address
2946 SCOTT BLVD., Santa Clara, CA 95054
Contract listings
2 device listings, 2 product codes, first listed Apr 17, 2019
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
LYRHelicobacter PyloriClass IMicrobiologyContract manufacturingApr 17, 2019
QKOReagent, Coronavirus SerologicalNot classifiedMicrobiologyContract manufacturingApr 2, 2020