FDA Registration
Active
🇨🇳 China
BEIJING HOTGEN BIOTECH CO., LTD.
Reg #: 3017894300
·
FEI: 3017894300
·
Expires 2026
Products
13
Proprietary Names
13
Establishment Types
1
Classifications
13
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Registration Details
- Registration Name
- BEIJING HOTGEN BIOTECH CO., LTD.
- Registration Number
- 3017894300
- FEI Number
- 3017894300
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1-5 floor, 7th Building No.55 Qingfeng West Road, Daxing Biomedical Base Zhongguancun Science Park Daxing District
- City
- Beijing
- Country
- CN
Owner / Operator
- Firm Name
- Beijing Hotgen Biotech Co., Ltd.
- Operator Number
- 10084151
- Address
- 1-5 floor, 7th Building No.55 Qingfeng West Road, Daxing Biomedical Base Zhongguancun Science Park Daxing District
- City
- Beijing
- State
- CN-NOTA
- Postal Code
- 102629
- Country
- CN
- Correspondent
- Hongrui Zhang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2026-03-02 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-04-25 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2026-04-29 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2026-04-29 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2026-04-29 |
Proprietary Names
Automatic Chemiluminescence Immunoassay Analyzer
Prolactin test (Chemiluminescence Immunoassay)
Growth Hormone test (Chemiluminescence Immunoassay)
Follicle-stimulating Hormone test (Chemiluminescence Immunoassay)
Total Thyroxine test (Chemiluminescence Immunoassay)
Estradiol test (Chemiluminescence Immunoassay)
Insulin test (Chemiluminescence Immunoassay)
Hotgen COVID-19 Antigen Home Test
C-Peptide test (Chemiluminescence Immunoassay)
Luteinizing Hormone test (Chemiluminescence Immunoassay)
Total Triiodothyronine test (Chemiluminescence Immunoassay)
Free Triiodothyronine test (Chemiluminescence Immunoassay)
Progesterone test (Chemiluminescence Immunoassay)
Establishment Types
Manufacture Medical Device