ASSURE TECH. (HANGZHOU) CO., LTD.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3009585529

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
3009585529
FEI Number
3009585529
Entity Name
ASSURE TECH. (HANGZHOU) CO., LTD.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou Zhejiang 310011, CN
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Assure Tech. (Hangzhou) Co., Ltd. (Owner Number: 10040710)
Owner / Operator Contact Address
Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou, CN-ZJ 310011, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233174
PMA Number
N/A

All Registered Proprietary Names

OralTox Oral Fluid Drug Test AssureTech Quick Cup Tests Areta Multi-Drug Test Cup, ACDOA-754 Areta Multi-Drug Test Cup, ACDOA-1144 AssureTech Multi-drug Urine Test Cup Blood Ketone Monitoring System for Keto Die Blood Ketone Test Strips for Keto Diet Rapid Diagnostic Tests FaStep Early Pregnancy Rapid Test Strip FaStep Early Pregnancy Rapid Test Midstream FaStep Early Pregnancy Rapid Test Cassette FaStep Pregnancy Rapid Test Cassette Fastep HCG Rapid Test Cassette Prabadin Drug Cup Test Areta Multi-Drug Screen Test, ADTP-6125B Areta Multi-Drug Screen Test, ADTP-3104 Easy@Home Cocaine Test Dip Card, EDCO-114 Areta Mutil-Drug Test Cup, ACDOA2-1134 Rapid Diagnostic Tests Easy@Home Multi-Drug Screen Test Carethetic Multi Drug Test Panel Easy@Home Multi-Drug Screen Test, EDOAP-754 Easy@Home Multi-Drug Screen Test, EDOAP-3104 Areta Multi-Drug Screen Test, ADTP-254 Easy@Home Multi-Drug Screen Test, EDOAP-174 Easy@Home Multi-Drug Screen Test, EDOAP-7104 Easy@Home Drug Test Cup, ECDOA-1144A3 Areta Multi-Drug Screen Test, ADTP-1124 Carethetic Multi Drug Test Cup Easy@Home Multi-Drug Screen Test, EDOAP-144 Easy@Home Multi-Drug Screen Test, EDOAP-865 Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114 Areta Mutil-Drug Test Cup, ACDOA2-2124 rapid diagnostic test Areta Mutil-Drug Test Cup, ACDOA2-3104 Identify® Diagnostics Multi-Drug Urine Test Cup Areta Multi-Drug Screen Test, ADTP-754 Easy@Home Multi-Drug Screen Test, EDOAP-6125B Easy@Home Multi-Drug Screen Test, EDOAP-1124 Easy@Home Multi-Drug Screen Test, EDOAP-254 Easy@Home Multi-Drug Screen Test, EDOAP-654 Easy@Home Multi-Drug Screen Test, EDOAP-264 Identify® Diagnostics Multi-Drug Urine Test Dip Easy@Home Drug Test Cup, ECDOA4-6125B DOA Saliva cup Rapid Diagnostic Tests Prabadin Cotinine Drug Test Cassette Easy@Home Cotintine Test Dip Card Easy@Home Cotintine Test Dip Card, ECOT-115 Easy@Home Cotinine Panel Dip Test, ECOT-114 Areta Single Drug Test easy@Home Nicotine Urine Test Cotinine Test Strip Areta Cotinine Test Strip, ASCOT-114C Rapid Diagnostic Tests OralTox® Oral Fluid Drug Test Rapid Diagnostic Tests DOA Saliva cup Rapid Diagnostic Tests Combo hCG Test Rapid Diagnostic Tests Prabadin HCG Pregnancy Test hCG Pregnancy Test Strip Maternova Pregnancy test Rapid Diagnostic Tests Rapid Response At-Home Pregnancy Test FaStep Rapid Fentanyl Urine Test FaStep Fentanyl Rapid Test Device easy@Home Fentanyl Urine Test(Cassette), ECFY-114 Maternova Fentanyl rapid test DOA Saliva cup Rapid Diagnostic Tests DOA Saliva cup Rapid Diagnostic Tests Rapid Diagnostic Tests VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT / TEST DIP CARD MULTI DRUG Rapid Response Drug Screening Panel Rapid Response Drug Screening Cup Premier Bio-Cup Tests rapid diagnostic test Premier Bio-Panel Dip Tests VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT /MULTI TEST CUP Fertility Combo Rapid Test (Urine) Rapid Diagnostic Tests HealCare FSH Menopause Rapid Test DOA Saliva cup Rapid Diagnostic Tests Easy@Home Marijuana Test Dip Card EDTH-115 Areta Marijuana Test Strip, ASTH-114C Carethetic Marijuana Test Kit (THC urine test) Rapid Diagnostic Tests Easy@Home Single Drug Screen Test (Marijuana Urine Test), EDTH-114 VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/PHENCYCLIDINE TEST STRIP VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/METHAMPHETAMINE TEST STRIP Easy@Home Multi-Drug Screen Test, EDOAP-124 VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/MARIJUANA TEST STRIP Easy@Home Marijuana Test Strips, ESTH-115 Easy@Home Marijuana Test Cup, ECTH4-114A3 Easy@Home Marijuana Test Strip DOA Saliva cup Rapid Diagnostic Tests Rapid Diagnostic Tests Rapid Diagnostic Tests Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114 Rapid Diagnostic Tests Areta Cocaine Test Strip (ASCOC-114) PdG Rapid Test Fertility Combo Rapid Test (Urine) Vaginal pH Test Device Fastep COVID-19 Antigen Pen Test Fastep COVID-19 Antigen Pen Home Test FaStep Pregnancy Rapid Test Strip FaStep Pregnancy Rapid Test Midstream EASY@HOME PREGNANCY TEST, EZW1-MD

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 2018-09-25
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-09-25
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-09-25
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-09-25
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-09-25
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-09-25
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-09-23
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-09-23
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-09-23
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-09-23
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-09-23
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-09-23
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-09-23
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-09-23
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-09-23
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-09-23
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-09-23
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2026-05-26
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-03-22
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2025-03-18
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2025-03-18
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2025-03-18
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2018-04-16
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-04-16
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-04-16
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-04-16
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-04-16
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-04-16
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2018-04-16
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-04-16
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-04-16
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2018-04-16
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-04-16
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2021-03-11
MRS Test System, Nicotine, Cotinine, Metabolites Clinical Toxicology Class 1 862.3220 2020-03-29
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2014-09-25
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-10-07
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-10-07
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-10-07
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-10-07
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-10-07
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-10-07
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-10-07
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2015-01-12
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2015-01-12
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2021-03-11
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2016-09-14
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2013-04-11
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-03-08
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2021-03-11
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2021-03-11
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2018-09-02
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-09-02
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-09-02
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-09-02
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2018-09-02
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-09-02
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-09-02
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-09-02
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2018-09-02
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-09-02
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-09-02
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2013-08-22
PUY Test, Barbiturate, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3150 2021-03-11
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2016-09-14
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2016-09-14
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2016-09-14
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2021-03-11
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2013-06-20
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2013-06-20
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2013-06-20
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2013-06-20
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2013-06-20
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2013-06-20
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2013-06-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2016-09-14
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2016-09-14
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2016-09-14
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2016-09-14
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2016-09-14
QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter Clinical Chemistry Class 1 862.1620 2025-09-23
LNW Paper, Obstetric Ph Clinical Chemistry Class 1 862.1550 2024-10-22
QYT Over-The-Counter Covid-19 Antigen Test Microbiology Class 2 866.3984 2026-06-10
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-03-08

Official Correspondent

Shisheng Ling

US Agent Details

Allen Chen Email: ra@assuretechusa.com Phone: (301) 2500831

Related Public Records

Same Entity

Assure Tech. (Hangzhou) Co., Ltd.
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 3009585529. Last updated year: 2026. Please use registration number 3009585529 when referencing this establishment in official correspondence.
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