Acon Biotech (Hangzhou) Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 29 device types.
Acon Biotech (Hangzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Control, Hemoglobin, Test, Urine Leukocyte and 27 other device types. Its earliest product listing with the FDA dates from 2006.
29device types registered with the FDA
1recall
Registration
| Registered name | ACON BIOTECH (HANGZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9615507 |
| FEI number | 3002829675 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 艾康生物技术（杭州）有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No. 210 Zhenzhong Road |
| Postal code | 310030 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Class 1 | Mission U120 Smart Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 10 |
| Automated Urinalysis System | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer | 2008 | 16 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 12 |
| Blood, Occult, Colorimetric, In Urine | Class 2 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 5 |
| Calculator/Data Processing Module, For Clinical Use | Class 1 | On Call Diabetes Monitoring Software | 2014 | 7 |
| Colorimetric Method, Triglycerides | Class 1 | Mission Cholesterol CTRL Control Device, Mission Cholesterol Control Solution, Mission Cholesterol Meter, Mission Cholesterol Test Device → 3-in-1 Lipid Panel | 2017 | 5 |
| Control, Hemoglobin | Class 2 | Mission Plus Hemoglobin Testing System | 2013 | 2 |
| Covid-19 Multi-Analyte Antigen Device | Class N | 2024 | 7 | |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | Mission U120 Smart Urine Analyzer, HealthyMe Urinary Tract Infection Test Strips, Mission UTI Urinary Tract Infection Test Strips, Vivoo At-Home Urinary Tract Infection Test, Test Yourself @ Home Urinary Tract Infection Test Strips, Mission U120 Touch Urine Analyzer and 2 more | 2006 | 14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 11 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 16 |
| Enzymatic Esterase–Oxidase, Cholesterol | Class 1 | Mission Cholesterol CTRL Control Device, Mission Cholesterol Control Solution, Mission Cholesterol Meter, Mission Cholesterol Test Device → 3-in-1 Lipid Panel | 2017 | 9 |
| Enzymatic Method, Creatinine | Class 2 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine), Mission U120 Touch Urine Analyzer | 2015 | 4 |
| Glucose Oxidase, Glucose | Class 2 | On Call Vivid Blood Glucose Monitoring System, On Call Express Blood Glucose Monitoring System, On Call Plus Blood Glucose Monitoring System, On Call Pro Blood Glucose Monitoring System | 2009 | 8 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | 2006 | 14 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Test Yourself @ Home Digital Pregnancy Test, HealthyMe® Digital Pregnancy Test, Distinct® Early Detection Pregnancy Test, HealthyMe® Early Detection Pregnancy Test | 2022 | 30 |
| Ldl & Vldl Precipitation, Hdl | Class 1 | Mission Cholesterol CTRL Control Device, Mission Cholesterol Control Solution, Mission Cholesterol Meter, Mission Cholesterol Test Device → 3-in-1 Lipid Panel | 2017 | 3 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class 2 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 5 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, KetoTrak Blood Ketone Monitoring System, On Call Sure Sync GK Blood Glucose and Ketone Monitoring System, On Call Sure GK Blood Glucose and Ketone Monitoring System and 2 more | 2006 | 17 |
| Over-The-Counter Covid-19 Antigen Test | Class 2 | 2024 | 5 | |
| Refractometer For Clinical Use | Class 1 | Mission U120 Smart Urine Analyzer, Mission U120 Touch Urine Analyzer, Mission U500 Urine Analyzer, Acon Urinalysis Reagent Strips, Mission Urinalysis Reagent Strips | 2006 | 8 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | Class 1 | On Call Vivid Blood Glucose Monitoring System, On Call Express Blood Glucose Monitoring System, On Call Plus Blood Glucose Monitoring System | 2009 | 12 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | On Call Stealth Lancing Device, On Call Lancing Device | 2012 | 36 |
| System, Hemoglobin, Automated | Class 2 | Mission Plus Hemoglobin Testing System | 2013 | 1 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | On Call Express Voice Blood Glucose Monitoring System, On Call Stealth Lancing Device, On Call Lancing Device, On Call Diabetes Monitoring Software, On Call Vivid Blood Glucose Monitoring System, On Call Sure Sync GK Blood Glucose and Ketone Monitoring System and 5 more | 2009 | 20 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | HealthyMe® Ovulation Test | 2024 | 38 |
| Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | Class 1 | Mission U500 Urine Analyzer | 2012 | 1 |
| Test, Urine Leukocyte | Class 1 | Mission U120 Smart Urine Analyzer, HealthyMe Urinary Tract Infection Test Strips, Mission UTI Urinary Tract Infection Test Strips, Vivoo At-Home Urinary Tract Infection Test, Test Yourself @ Home Urinary Tract Infection Test Strips, Mission U120 Touch Urine Analyzer and 3 more | 2006 | 16 |
| Urinalysis Controls (Assayed And Unassayed) | Class 1 | Mission Liquid Diptube Urine Control, Mission Liquid Urine Control | 2011 | 3 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-01-09 | Class II | No Marketing Application | Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results. | 303,760 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Main products | POCT systems, Rapid diagnostics, Biochemical diagnostics, Chronic disease management, Molecular diagnostics |
| Certifications | FDA, CE, ISO13485:2016 |
| Export markets | 100+ sales regions globally; 2 billion+ test strips produced annually |
| OEM and ODM | Offered |
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.
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