HEALSTONE BIOTECH INC.

FDA Device Registration & Listing · Vancouver British Columbia, CA · Registration 3014301129

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
3014301129
FEI Number
3014301129
Entity Name
HEALSTONE BIOTECH INC.
City/State/Country
Vancouver British Columbia, CA
Establishment Address
Unit #650 - 655 West Kent Avenue North, Vancouver British Columbia V6P 6T7, CA
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Healstone Biotech Inc. (Owner Number: 10056764)
Owner / Operator Contact Address
Unit 650, 655 West Kent Ave. N., Vancouver, CA-BC V6P6T7, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212418
PMA Number
N/A

All Registered Proprietary Names

Abbott iSCREEN URINE TEST DRUG SCREEN CLICK CUP Rite Aid Corporation Rite Aid Drug Test Kit Abbott iSCREEN URINE TEST DRUG SCREEN FLAT CUP Healstone Biotech Inc. Accurate Multi Panel Drug Urine Test Cup Healstone Accurate Drug of Abuse Urine Test Cup Healstone hCG One Step Pregnancy Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2019-08-13
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2019-08-13
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2019-08-13
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2019-08-13
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2019-08-13
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2019-08-13
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2019-08-13
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2019-08-13
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2019-08-13
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2019-08-13
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2019-08-13
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2022-08-31
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2022-08-31
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2022-08-31
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2022-08-31
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2022-08-31
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2022-08-31
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2022-08-31
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2022-08-31
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2022-08-31
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2022-08-31
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2022-08-31
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2023-05-19

Official Correspondent

Chichi Liu

US Agent Details

Bryan Fang Email: bryan.fang@healgen.com Phone: (281) 8571217

Related Public Records

Same Entity

Healstone Biotech 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
K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25
K260065 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx 2026-04-28
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03
K241741 Guangzhou Wondfo Biotech Co., Ltd. SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 2024-07-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014301129. Last updated year: 2026. Please use registration number 3014301129 when referencing this establishment in official correspondence.
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