CITEST DIAGNOSTICS INC.

FDA Device Registration & Listing · VANCOUVER British Columbia, CA · Registration 3023296261

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
3023296261
FEI Number
3023296261
Entity Name
CITEST DIAGNOSTICS INC.
City/State/Country
VANCOUVER British Columbia, CA
Establishment Address
170-422, RICHARDS ST, VANCOUVER British Columbia V6B 2Z4, CA
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Citest Diagnostics Inc. (Owner Number: 10090628)
Owner / Operator Contact Address
170-422, RICHARDS ST, VANCOUVER, CA-BC V6B 2Z4, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Citest Multiplex DOA Home Test Cup (Urine) Citest Multiplex DOA Home Test Panel (Urine) Citest Multiplex DOA Test Panel (Urine) Citest Multiplex DOA Test Cup (Urine)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2024-04-21
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-04-21
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-04-21
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-04-21
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-04-21
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-04-21
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-04-21
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2024-04-21
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2024-04-21
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-04-21
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2024-04-21
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2024-04-21
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-04-21
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2024-04-21
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2024-04-21
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-04-21
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2024-04-21
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-04-21
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-04-21
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-04-21
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2024-04-21
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2024-04-21
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-04-21

Official Correspondent

Tracy Wu

US Agent Details

MANDY ZHAO Business: ACESO LABORATORIES INC. Email: info@acesolab.com Phone: (909) 9541508

Related Public Records

Same Entity

Citest 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
K110182 Guangzhou Wondfo Biotech Co., Ltd. CANNABINOIDS URINE TEST 2011-05-20
K121557 Guangzhou Wondfo Biotech Co., Ltd. WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST 2012-07-25
K920418 Instrumentation Laboratory CO IL TEST CANNABINOID, 35282 1992-02-27
K924751 Solarcare Technologies Corp,Inc. SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY 1992-12-11
K142044 Guangzhou Wondfo Biotech Co., Ltd. CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE 2014-08-25

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 3023296261. Last updated year: 2026. Please use registration number 3023296261 when referencing this establishment in official correspondence.
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