FDA Registration
Active
🇨🇳 China
Xenta Drug Screen Cup ,Xenta Drug Screen Dipcard
Reg #: 3023330725
·
FEI: 3023330725
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- XENTA BIOMEDICAL SCIENCE CO., LTD.
- Registration Number
- 3023330725
- FEI Number
- 3023330725
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231137
Owner / Operator
- Firm Name
- Xenta Biomedical Science Co., Ltd.
- Operator Number
- 10085227
- Address
- Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, Huangpu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510535
- Country
- CN
- Correspondent
- Ling Huang
US Agent
- Business Name
- XENTA BIOMEDICAL SCIENCE CO.
- Contact Name
- LIN XI
- Address
- 10333 HARWIN DR STE 375J
- City
- Houston
- State
- TX
- ZIP
- 77036
- Country
- US
- [email protected]
- Phone
- 713 3196311
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-05-23 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-05-23 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-05-23 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-05-23 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-05-23 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-05-23 |
Proprietary Names
Xenta Drug Screen Cup ,Xenta Drug Screen Dipcard
Establishment Types
Manufacture Medical Device