FDA Registration
Active
🇨🇳 China
Hightop® Multi-Drug Urine Test Cup
Reg #: 3014223276
·
FEI: 3014223276
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- QINGDAO HIGHTOP BIOTECH CO., LTD.
- Registration Number
- 3014223276
- FEI Number
- 3014223276
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.369 Hedong Road, Hi-tech Industrial Development Zone
- City
- Qingdao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220685
Owner / Operator
- Firm Name
- Qingdao HIGHTOP Biotech Co., Ltd.
- Operator Number
- 10061479
- Address
- No.369 Hedong Road, Hi-tech Industrial Development Zone
- City
- Qingdao
- State
- Shandong
- Postal Code
- 266112
- Country
- CN
US Agent
- Business Name
- LSI
- Contact Name
- Joe Xia
- Address
- 504E Diamond Ave., Suite J
- 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, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-05-07 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2022-05-07 |
Proprietary Names
Hightop® Multi-Drug Urine Test Cup
Hightop® Multi-Drug Urine Test Cup Rx
Establishment Types
Manufacture Medical Device