Beijing Hotgen Biotech Co., Ltd.
Manufacturer and brand owner in Beijing, China. 13 device types, 1 product catalogued.
Beijing Hotgen Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Radioimmunoassay, Estradiol, Radioimmunoassay, Progesterone and 11 other device types. Its earliest product listing with the FDA dates from 2022.
13device types registered with the FDA
1product
Registration
| Registered name | BEIJING HOTGEN BIOTECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017894300 |
| FEI number | 3017894300 |
| DUNS | 529379019 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京热景生物技术股份有限公司 |
|---|---|
| Unified social credit code | 91110115777090586H |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | 1-5 floor, 7th Building No.55 Qingfeng West Road |
| Postal code | 102629 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | Automatic Chemiluminescence Immunoassay Analyzer | 2026 | 16 |
| Coronavirus Antigen Detection Test System. | Class N | Hotgen™ COVID-19 Antigen Home Test | 2022 | 12 |
| Radioassay, Triiodothyronine Uptake | Class 2 | Free Triiodothyronine test (Chemiluminescence Immunoassay) | 2026 | 2 |
| Radioimmunoassay, C-Peptides Of Proinsulin | Class 1 | C-Peptide test (Chemiluminescence Immunoassay) | 2026 | 6 |
| Radioimmunoassay, Estradiol | Class 1 | Estradiol test (Chemiluminescence Immunoassay) | 2026 | 5 |
| Radioimmunoassay, Follicle-Stimulating Hormone | Class 1 | Follicle-stimulating Hormone test (Chemiluminescence Immunoassay) | 2026 | 6 |
| Radioimmunoassay, Human Growth Hormone | Class 1 | Growth Hormone test (Chemiluminescence Immunoassay) | 2026 | 5 |
| Radioimmunoassay, Immunoreactive Insulin | Class 1 | Insulin test (Chemiluminescence Immunoassay) | 2026 | 4 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Luteinizing Hormone test (Chemiluminescence Immunoassay) | 2026 | 16 |
| Radioimmunoassay, Progesterone | Class 1 | Progesterone test (Chemiluminescence Immunoassay) | 2026 | 4 |
| Radioimmunoassay, Prolactin (Lactogen) | Class 1 | Prolactin test (Chemiluminescence Immunoassay) | 2026 | 6 |
| Radioimmunoassay, Total Thyroxine | Class 2 | Total Thyroxine test (Chemiluminescence Immunoassay) | 2026 | 5 |
| Radioimmunoassay, Total Triiodothyronine | Class 2 | Total Triiodothyronine test (Chemiluminescence Immunoassay) | 2026 | 5 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | IVD diagnostic platforms, chemiluminescence immunoassay, rapid diagnostic tests, antibody medicines |
| Certifications | 70+ patents, Shanghai Stock Exchange listed (688068) |
| Export markets | 50+ countries across 4 continents |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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