FDA Registration
Active
🇨🇳 China
Hangzhou Biotest Biotech Co.,Ltd.
Reg #: 3011522054
·
FEI: 3011522054
·
Expires 2026
Products
41
Proprietary Names
9
Establishment Types
3
Classifications
41
Registration Details
- Registration Name
- Hangzhou Biotest Biotech Co.,Ltd.
- Registration Number
- 3011522054
- FEI Number
- 3011522054
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17#,Futai Road,Zhongtai Street,Yuhang
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Hangzhou Biotest Biotech Co.,Ltd.
- Operator Number
- 10048622
- Address
- 17#,Futai Road,Zhongtai Street,Yuhang
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
- Correspondent
- WADE WU
US Agent
- Business Name
- Advin Biotech, Inc
- Contact Name
- Daniel Hsu
- Address
- 10237 Flanders Ct, San Diego, CA 92121
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 858 8668382
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2024-07-17 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2024-07-17 |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | Class 1 | Clinical Toxicology | No | 2022-04-26 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2025-03-13 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2024-07-17 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2025-03-13 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2015-02-04 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | PVK | Class 2 | Clinical Toxicology | No | 2025-03-13 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2022-04-24 |
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | Class 2 | Clinical Toxicology | No | 2025-03-13 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2015-06-05 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2015-06-05 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2020-12-31 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2025-03-13 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2024-07-17 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2024-07-17 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-02-24 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2022-04-24 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2025-11-18 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2025-11-18 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2015-10-26 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | PVI | Class 2 | Clinical Toxicology | No | 2025-03-13 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-20 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2022-04-24 |
Proprietary Names
COT Rapid Test Cassette (Urine)
Advin Multi-Drug Screen Test
ATTEST Drug Screen Dip Card
ATTEST Drug Screen Cup
OralTox Oral Fluid Drug Test
Rightsign Ms.Tellme
RightSign COVID-19 IgG/IgM Rapid Test Cassette
CoronaCheck COVID-19 IgG/IgM Rapid Test Cassette
Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198