Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 48 device types, 55 products catalogued, 7 clearances.
Assure Tech. (Hangzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Paper, Obstetric Ph, Enzyme Immunoassay, Opiates and 46 other device types. 52 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
48device types registered with the FDA
55products catalogued under its own name
7510(k) clearances
Registration
| Registered name | ASSURE TECH. (HANGZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009585529 |
| FEI number | 3009585529 |
| DUNS | 530757741 |
| Establishment type | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州安旭生物科技股份有限公司 |
|---|---|
| Unified social credit code | 913301066767726252 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Building 4, No. 1418-50, Moganshan Road, Gongshu District |
| Postal code | 310011 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | Class 1 | Breath Alcohol Test | 2023 | 16 |
| Enzyme Immunoassay, Amphetamine | Class 2 | Rapid Diagnostic Tests, Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114, Areta Cocaine Test Strip (ASCOC-114), Assuretech DOA Dipstick Screen Panel Tests, Assuretech DOA Integrated CUP Tests, OralTox® Oral Fluid Drug Test | 2013 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | Rapid Diagnostic Tests, Assuretech DOA Dipstick Screen Panel Tests, Assuretech DOA Integrated CUP Tests | 2016 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | Rapid Diagnostic Tests, Assuretech DOA Dipstick Screen Panel Tests, Assuretech DOA Integrated CUP Tests | 2013 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | Rapid Diagnostic Tests, Carethetic Marijuana Test Kit (THC urine test), Easy@Home Marijuana Test Dip Card EDTH-115, Easy@Home Marijuana Test Strips, ESTH-115, VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/PHENCYCLIDINE TEST STRIP, VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/MARIJUANA TEST STRIP and 9 more | 2013 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | Rapid Diagnostic Tests, Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114, Areta Cocaine Test Strip (ASCOC-114), Assuretech DOA Dipstick Screen Panel Tests, Assuretech DOA Integrated CUP Tests, OralTox® Oral Fluid Drug Test | 2013 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | Assuretech DOA Dipstick Screen Panel Tests, Rapid Diagnostic Tests, Assuretech DOA Integrated CUP Tests, OralTox® Oral Fluid Drug Test | 2016 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | Rapid Diagnostic Tests, Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114, Areta Cocaine Test Strip (ASCOC-114), Assuretech DOA Dipstick Screen Panel Tests, Assuretech DOA Integrated CUP Tests, OralTox® Oral Fluid Drug Test | 2016 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | Rapid Diagnostic Tests, Carethetic Marijuana Test Kit (THC urine test), Easy@Home Marijuana Test Dip Card EDTH-115, Easy@Home Marijuana Test Strips, ESTH-115, VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/PHENCYCLIDINE TEST STRIP, VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/MARIJUANA TEST STRIP and 9 more | 2013 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | Assuretech DOA Dipstick Screen Panel Tests, Rapid Diagnostic Tests, Assuretech DOA Integrated CUP Tests | 2021 | 10 |
| Gas Chromatography, Methamphetamine | Class 2 | Rapid Diagnostic Tests, Assuretech DOA Dipstick Screen Panel Tests, Assuretech DOA Integrated CUP Tests | 2015 | 10 |
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | Class 1 | Fertility Combo Rapid Test (Urine), PdG Rapid Test | 2025 | 4 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Fastep HCG Rapid Test Cassette, FaStep Pregnancy Rapid Test Cassette, FaStep Early Pregnancy Rapid Test Strip, FaStep Early Pregnancy Rapid Test Cassette, FaStep Early Pregnancy Rapid Test Midstream, FaStep Pregnancy Rapid Test Midstream and 4 more | 2013 | 30 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | Blood Ketone Test Strips for Keto Diet, Blood Ketone Monitoring System for Keto Die | 2026 | 17 |
| Over-The-Counter Covid-19 Antigen Test | Class 2 | Fastep COVID-19 Antigen Pen Home Test, Fastep COVID-19 Antigen Pen Test | 2026 | 5 |
| Paper, Obstetric Ph | Class 1 | Vaginal pH Test Device | 2024 | 13 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | Assuretech DOA Dipstick Screen Panel Tests, Rapid Diagnostic Tests, Assuretech DOA Integrated CUP Tests | 2021 | 9 |
| Reagent, Coronavirus Serological | Class N | Rapid Diagnostic Tests | 2020 | 12 |
| Sperm, Antigen, Antiserum, Control | Class 1 | Home Sperm Test for Male Fertility | 2026 | 5 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | Easy@Home Cotintine Test Dip Card, ECOT-115, Areta Single Drug Test, Prabadin Cotinine Drug Test Cassette, Easy@Home Cotinine Panel Dip Test, ECOT-114, easy@Home Nicotine Urine Test, Easy@Home Cotintine Test Dip Card and 2 more | 2020 | 11 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 16 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 11 |
| Test, Barbiturate, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 16 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 11 |
| Test, Benzodiazepine, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 16 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | DOA Saliva cup | 2021 | 12 |
| Test, Cannabinoid, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 16 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | HealCare FSH Menopause Rapid Test, Rapid Diagnostic Tests, Fertility Combo Rapid Test (Urine) | 2013 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Rapid Diagnostic Tests, LH One Step Ovulation Test, Digital Fertility Tracker, HealCare LH Ovulation Rapid Test, Digital LH Test, Easy@Home Ovulation Test, EZW2-S and 2 more | 2013 | 38 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 11 |
| Test, Methadone, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 17 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | DOA Saliva cup, Rapid Diagnostic Tests | 2021 | 13 |
| Test, Methamphetamine, Over The Counter | Class 2 | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 16 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | Class 2 | DOA Saliva cup, Rapid Diagnostic Tests | 2021 | 6 |
| Test, Morphine, Employment And Insurance Testing, Exempt | Class 2 | DOA Saliva cup, Rapid Diagnostic Tests | 2021 | 8 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 12 |
| Test, Opiates, Over The Counter | Class 2 | Rapid Diagnostic Tests, FaStep Rapid Fentanyl Urine Test, Maternova Fentanyl rapid test, easy@Home Fentanyl Urine Test(Cassette), ECFY-114, FaStep Fentanyl Rapid Test Device, Areta Multi-Drug Test Cup, ACDOA-754 and 44 more | 2017 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | Rapid Diagnostic Tests, Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests and 40 more | 2017 | 12 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | Class 2 | DOA Saliva cup, Rapid Diagnostic Tests | 2021 | 7 |
| Test, Propoxyphene, Over The Counter | Class 2 | Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests, Rapid Diagnostic Tests and 40 more | 2018 | 16 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | Class 2 | Rapid Diagnostic Tests, DOA Saliva cup | 2021 | 7 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | Areta Multi-Drug Test Cup, ACDOA-754, AssureTech Quick Cup Tests, Areta Multi-Drug Test Cup, ACDOA-1144, AssureTech Multi-drug Urine Test Cup, Premier Bio-Panel Dip Tests, Rapid Diagnostic Tests and 40 more | 2018 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | Rapid Diagnostic Tests, Carethetic Marijuana Test Kit (THC urine test), Easy@Home Marijuana Test Dip Card EDTH-115, Easy@Home Marijuana Test Strips, ESTH-115, VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/PHENCYCLIDINE TEST STRIP, VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/MARIJUANA TEST STRIP and 7 more | 2013 | 12 |
| Thin Layer Chromatography, Morphine | Class 2 | Rapid Diagnostic Tests | 2013 | 4 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | Fastep HCG Rapid Test Cassette, FaStep Pregnancy Rapid Test Cassette, Rapid Response Pregnancy Test 20mIU, Rapid Diagnostic Tests, Combo hCG Test, Prabadin HCG Pregnancy Test and 2 more | 2012 | 16 |
Own-Brand Listings
Clearances
7 clearances name Assure Tech. (Hangzhou) Co., Ltd. as applicant. 11 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233174 | 2024-02-05 | LCX | Traditional | This company |
| K201630 | 2021-08-12 | DJG | Traditional | This company |
| K181768 | 2018-08-20 | NFT | Traditional | This company |
| K180349 | 2018-04-05 | NFT | Traditional | This company |
| K170049 | 2017-05-02 | NFT | Traditional | This company |
| K161044 | 2016-07-06 | DJC | Traditional | This company |
| K153465 | 2016-03-31 | DKZ | Traditional | This company |
| K260754 | 2026-06-05 | QYT | Traditional | Assure Tech LLC |
| K252259 | 2025-08-15 | NFT | Traditional | Assure Tech LLC |
| K250117 | 2025-02-13 | LCX | Traditional | Assure Tech LLC |
| K243996 | 2025-02-07 | NFT | Traditional | Assure Tech LLC |
| K243573 | 2025-01-15 | LCX | Traditional | Assure Tech LLC |
| K240351 | 2024-03-06 | NGL | Traditional | Assure Tech LLC |
| K152768 | 2016-02-24 | JHI | Traditional | Assure Tech LLC |
| K152025 | 2015-10-05 | DJR | Traditional | Assure Tech LLC |
| K151211 | 2015-06-04 | DIS | Traditional | Assure Tech LLC |
| K122907 | 2013-03-14 | LCX | Traditional | Polymed Therapeutics, Inc. |
| K112101 | 2012-07-17 | JHI | Traditional | Polymed Therapeutics, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 950 |
| Main products | Drug of Abuse Tests, Infectious Disease Tests, Fertility Tests, Cardiac Marker Tests, Tumor Marker Tests |
| Export markets | 150+ service regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.