FDA Registration
Active
🇨🇳 China
CLUNGENE® Multi-Drug Test Cup
Reg #: 3009414546
·
FEI: 3009414546
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HANGZHOU CLONGENE BIOTECH CO., LTD.
- Registration Number
- 3009414546
- FEI Number
- 3009414546
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.1 Yichuang Road, Yuhang Sub-district, Yuhang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181790
Owner / Operator
- Firm Name
- Hangzhou Clongene Biotech Co., Ltd.
- Operator Number
- 10051623
- Address
- No.1 Yichuang Road, Yuhang Sub-district, Yuhang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
- Correspondent
- Shujian Zheng
US Agent
- Business Name
- LSI International Inc
- Contact Name
- Joe Xia
- Address
- 504 E Diamond Ave Ste I
- City
- Gaithersburg
- State
- MD
- ZIP
- 20877
- Country
- US
- [email protected]
- Phone
- 240 5057880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2018-11-02 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2018-11-02 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2018-11-02 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2018-11-02 |
Proprietary Names
CLUNGENE® Multi-Drug Test Cup
CLUNGENE® Multi-Drug Test Dip Card
Establishment Types
Manufacture Medical Device