LUMIQUICK DIAGNOSTICS, INC.

FDA Device Registration & Listing · SANTA CLARA, CA, US · Registration 3005984081

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005984081
FEI Number
3005984081
Entity Name
LUMIQUICK DIAGNOSTICS, INC.
City/State/Country
SANTA CLARA, CA, US
Establishment Address
2946 SCOTT BLVD., SANTA CLARA, CA 95054, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LUMIQUICK DIAGNOSTICS, INC. (Owner Number: 9093981)
Owner / Operator Contact Address
2946 SCOTT BLVD., --, Santa Clara, CA 95054, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K981770
PMA Number
N/A

All Registered Proprietary Names

SARS-CoV-2 Antibody Test Card QuickProfile S. typhi IgG/IgM Duo Test QuickProfile Rapid Urine Fentanyl (FTL) Test DipCard QuickProfile Rapid Urine Fentanyl (FTL) Test Card QuickProfile Rapid Urine Fentanyl (FTL) Test Strip Rapid SARS-CoV-2 Antigen Test Card - for lay use Rapid SARS-CoV-2 Antigen Test Card - Outside a hospital other clinical setting Rapid SARS-CoV-2 Antigen Test Card Rapid SARS-CoV-2 Antigen Test Card - in community Rapid SARS-CoV-2 Antigen Test Card - a combination of clinical and non-clinical settings Rapid SARS-CoV-2 Antigen Test Card - for person use QuickProfile HCG Tests QuickProfile™ HCG Test Strip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2017-10-30
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2017-10-30
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2017-10-30
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2017-10-30
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2017-10-30
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2017-10-30
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2015-10-28
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2017-10-30
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2017-10-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2017-10-30
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2017-10-30
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2017-10-30
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2017-10-30
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2017-10-30
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2017-10-30
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2017-10-30
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2017-10-30
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2015-10-28
NED N/A N/A Class N/A N/A 2013-01-02
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2010-11-12
PYS Zika Virus Serological Reagents (Emergency Use) Unknown Class N N/A 2019-06-05
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-04-01
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus Microbiology Class 1 866.3405 2007-12-05
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-02-19
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-02-19
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-02-19
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-02-19
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-02-19
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-02-19
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-02-19
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-02-19
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2024-02-19
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-02-19
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-02-19
MJH Legionella, Spp., Elisa Microbiology Class 2 866.3300 2013-01-02
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2015-10-28
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2015-10-28
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2008-12-02
DMJ Test Reagents For Ethyl Alcohol Clinical Toxicology Class 2 862.3040 2017-11-28
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2015-10-28
GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. Microbiology Class 2 866.3550 2013-11-08
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2025-08-19
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-02-19
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-02-19
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-02-19
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-02-19
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2024-02-19
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-02-19
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-02-19
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-02-19
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-02-19
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-02-19
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-02-19
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-08-19
NWY Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies Unknown Class N N/A 2007-12-05
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2008-12-02
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2017-10-30
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2015-10-28
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2015-10-28
DKX Thin Layer Chromatography, Barbiturate Clinical Toxicology Class 2 862.3150 2017-10-30
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2022-04-12
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2013-11-08
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2013-11-08
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2013-11-08
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2013-11-08
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2013-11-08
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2013-11-08
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2013-11-08
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2013-11-08
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2013-11-08
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2022-04-12
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2025-08-19
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-04-02
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2015-10-28
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2015-10-28
JLB Atp And Creatine Kinase (Enzymatic), Creatine Clinical Chemistry Class 1 862.1210 2013-01-02
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2017-10-30
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2017-10-30
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2017-10-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2017-10-30
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2017-10-30
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2017-10-30
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2017-10-30
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2017-10-30
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2017-10-30
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2023-08-30
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2017-11-10

Official Correspondent

Chih Wang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LUMIQUICK DIAGNOSTICS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26
K151478 Guangzhou Wondfo Biotech Co., Ltd. Wondfo CR3 Keyless Split Sample Cup 2015-07-01
K150179 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 2015-02-25
K112310 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST,OPIATE TEST 2011-09-08
K093175 Guangzhou Wondfo Biotech Co., Ltd. WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES 2010-08-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005984081. Last updated year: 2026. Please use registration number 3005984081 when referencing this establishment in official correspondence.
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