Xiamen Boson Biotech Co., Ltd.
Manufacturer and brand owner in Xiamen, Fujian, China. 6 device types, 8 products catalogued.
Xiamen Boson Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Coronavirus Antigen Detection Test System., Test, Luteinizing Hormone (Lh), Over The Counter and 4 other device types. Its earliest product listing with the FDA dates from 2020.
6device types registered with the FDA
8products catalogued under its own name
Registration
| Registered name | XIAMEN BOSON BIOTECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008825965 |
| FEI number | 3008825965 |
| DUNS | 527409818 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 厦门市波生生物技术有限公司 |
|---|---|
| Unified social credit code | 91350200705468594R |
| Source | NMPA UDI database |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | 90-94 Tianfeng Road |
| Postal code | 361021 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Coronavirus Antigen Detection Test System. | Class N | 2022 | 12 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | 2020 | 11 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | 2020 | 12 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | 2020 | 38 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | 2020 | 13 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | 2020 | 12 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Factory area | 12500 m² |
| Main products | IVD rapid test kits, Immunofluorescence test kits, Chemiluminescence immunoassay kits, Fluorescence analyzers, Antibodies and antigens |
| Certifications | ISO13485:2016, GMP, NMPA, EU IVDR |
| Export markets | 70+ countries including Americas, Europe, Africa, Middle East, Southeast Asia |
| OEM and ODM | Offered |
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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