FDA Registration
Active
🇨🇳 China
ACON BIOTECH (HANGZHOU) CO., LTD.
Reg #: 9615507
·
FEI: 3002829675
·
Expires 2026
Products
29
Proprietary Names
34
Establishment Types
1
Classifications
29
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Registration Details
- Registration Name
- ACON BIOTECH (HANGZHOU) CO., LTD.
- Registration Number
- 9615507
- FEI Number
- 3002829675
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 210 Zhenzhong Road, West Lake District
- City
- HANGZHOU Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- ACON Laboratories Inc.
- Operator Number
- 9033096
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Catherine Shi
US Agent
- Business Name
- ACON LABORATORIES INC.
- Contact Name
- Catherine Shi
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 858 8758068
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2016-09-02 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2016-09-02 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2012-04-02 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2012-04-02 |
| Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | NGJ | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2012-04-02 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-05-17 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2012-05-17 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-04-15 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2013-08-19 |
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2013-08-19 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2015-07-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2008-01-29 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2024-07-23 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-01-08 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2017-09-05 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2017-09-05 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2017-09-05 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2024-06-26 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2024-06-26 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2011-11-17 |
Proprietary Names
On Call Pro Blood Glucose Monitoring System
Mission U500 Urine Analyzer
On Call Vivid Blood Glucose Monitoring System
On Call Lancing Device
On Call Stealth Lancing Device
Test Yourself @ Home Digital Pregnancy Test
HealthyMe® Digital Pregnancy Test
Mission Plus Hemoglobin Testing System
On Call Express Blood Glucose Monitoring System
On Call Express II Blood Glucose Monitoring System
KetoTrak Blood Ketone Monitoring System
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
Mission U120 Touch Urine Analyzer
On Call Express Voice Blood Glucose Monitoring System
On Call Plus Blood Glucose Monitoring System
HealthyMe® Early Detection Pregnancy Test
Distinct® Early Detection Pregnancy Test
On Call Diabetes Monitoring Software
ACON URINALYSIS REAGENT STRIPS
Mission Urinalysis Reagent Strips
Mission Cholesterol CTRL Control Device
Mission Cholesterol Test Device 3-in-1 Lipid Panel
Mission Cholesterol Control Solution
Mission Cholesterol Meter
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
On Call Sure Sync GK Blood Glucose and Ketone Monitoring System
On Call Sure GK Blood Glucose and Ketone Monitoring System
HealthyMe® Ovulation Test
Mission Liquid Diptube Urine Control
Mission Liquid Urine Control
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)