FDA Registration
Active
🇨🇳 China
QINGDAO HIGHTOP BIOTECH CO., LTD.
Reg #: 3014223276
·
FEI: 3014223276
·
Expires 2026
Products
14
Proprietary Names
11
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- QINGDAO HIGHTOP BIOTECH CO., LTD.
- Registration Number
- 3014223276
- FEI Number
- 3014223276
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.369 Hedong Road, Hi-tech Industrial Development Zone
- City
- Qingdao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241969
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, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2019-11-25 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2026-04-03 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-10-22 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2019-10-22 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-05-07 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-05-07 |
| Test, Amphetamine, Over The Counter | NFT | 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 (LH) Luteinizing Hormone Rapid Test Cassette
HIGHTOP (LH) Luteinizing Hormone Rapid Test Midstream
HIGHTOP (LH) Luteinizing Hormone Rapid Test Strip
FSH Rapid Test
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel
Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
HIGHTOP Pregnancy Rapid Test Strip
HIGHTOP Pregnancy Rapid Test Cassette
HIGHTOP Pregnancy Rapid Test Midstream
Hightop® Multi-Drug Urine Test Cup
Hightop® Multi-Drug Urine Test Cup Rx
Establishment Types
Manufacture Medical Device