FDA Registration
Active
🇨🇳 China
Rapid Diagnostic Tests
Reg #: 3009585529
·
FEI: 3009585529
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- ASSURE TECH. (HANGZHOU) CO., LTD.
- Registration Number
- 3009585529
- FEI Number
- 3009585529
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 4, No. 1418-50, Moganshan Road, Gongshu District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201630
Owner / Operator
- Firm Name
- Assure Tech. (Hangzhou) Co., Ltd.
- Operator Number
- 10040710
- Address
- Building 4, No. 1418-50, Moganshan Road, Gongshu District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310011
- Country
- CN
- Correspondent
- Shisheng Ling
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2021-09-07 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2021-09-07 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2021-09-07 |
Proprietary Names
Rapid Diagnostic Tests
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device