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Sign in to claim this brandXIAMEN BOSON BIOTECH CO., LTD.
China·CN-MF-000001096
Last updated September 17, 2026
Information
- Country
- China
- Address
- No. 90-94, Tianfeng Road, Xiamen, China
- Website
- www.bosonbio.com
- —
- —
- [email protected]
- Phone
- +86-592-3965101
- PRRC Contact
- Haolong Shen
- EUDAMED SRN
- CN-MF-000001096
- FDA FEI Number
- 3008825965
- DUNS Number
- —
Catalogue (287)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rapid Cotinine Test Card | 1L44C3 | EUDAMED | IVD General | Active |
| Rapid Cotinine Test Strip | 1L44S3 | EUDAMED | IVD General | Active |
| SARS-CoV-2 Neutralizing Antibody Test Card | 1N42C2 | EUDAMED | IVD General | Active |
| Troponin I Quantitative Test | 5J02C1 | EUDAMED | IVD General | Active |
| Rapid Opiate Test Strip | 1L11S3 | EUDAMED | IVD General | Active |
| Pepsinogen II assay (CLIA) | 7C17V1-B-EU, 7C17U1-B-EU, 7C17P1-B-EU | EUDAMED | IVD General | Active |
| Cystatin C Test (FIA) | 5M15C2-25-EU, 5M15C2-50-EU | EUDAMED | IVD General | Active |
| Rapid HAV IgG/IgM Combo Test Card | 1H16C2 | EUDAMED | IVD General | Active |
| Rapid HCG Pregnancy Urine Test Strip | 1D04S3 | EUDAMED | IVD General | Active |
| Sample Collection Tube | 1M01T0-A | EUDAMED | Class A | Active |
| Procalcitonin assay (CLIA) | 7M17V1-B-EU, 7M17U1-B-EU, 7M17P1-B-EU | EUDAMED | IVD General | Active |
| Rapid DOA-5 Panel Test Cup (Split type) | 1L21P3 | EUDAMED | IVD General | Active |
| Opiate Saliva Test Card | 1L11C5 | EUDAMED | IVD General | Active |
| Rapid Cocaine Test Strip | 1L05S3 | EUDAMED | IVD General | Active |
| Rapid DOA-9 Panel Test | 1L25M3 | EUDAMED | IVD General | Active |
| Rapid K2 Test Strip | 1L49S3 | EUDAMED | IVD General | Active |
| Anti-Müllerian Hormone assay (CLIA) | 7D06V1-B-EU, 7D06U1-B-EU, 7D06P1-B-EU | EUDAMED | IVD General | Active |
| Troponin I Test (FIA) | 5J02C1-25-EU, 5J02C1-50-EU | EUDAMED | IVD General | Active |
| β2-Microglobulin assay (CLIA) | 7M19V1-B-EU, 7M19U1-B-EU, 7M19P1-B-EU | EUDAMED | IVD General | Active |
| Rapid EDDP Test Card | 1L06C3 | EUDAMED | IVD General | Active |
| Rapid Methamphetamine Test Card | 1L10C3 | EUDAMED | IVD General | Active |
| Rapid SARS-CoV-2 Antigen Test Card | 1N40C5-8 | EUDAMED | IVD devices for self-testing | Active |
| Rapid Malaria pf/pv Antigen Test Card | 1Q07C2 | EUDAMED | IVD General | Active |
| Dengue IgG/IgM Combo Test (FIA) | 5N04C1-25-EU, 5N04C1-50-EU | EUDAMED | IVD General | Active |
| Rapid Amphetamine Test Card | 1L01C3 | EUDAMED | IVD General | Active |
| Rapid HCG Pregnancy Test Midstream | 1D04M3 | EUDAMED | IVD General | Active |
| C-Reactive Protein Test (FIA) | 5M13C2-25-EU, 5M13C2-50-EU | EUDAMED | IVD General | Active |
| Rapid Ketamine Test Card | 1L07C3 | EUDAMED | IVD General | Active |
| Calcitonin assay (CLIA) | 7M39V1-B-EU, 7M39U1-B-EU, 7M39P1-B-EU | EUDAMED | IVD General | Active |
| Myeloperoxidase Test (FIA) | 5J11C1-25-EU, 5J11C1-50-EU | EUDAMED | IVD General | Active |
| Rapid Dengue NS1 Antigen and IgG/IgM Duo Panel Test Card | 1N24C2 | EUDAMED | IVD General | Active |
| Cancer Antigen 15-3 assay (CLIA) | 7C10V1-B-EU, 7C10U1-B-EU, 7C10P1-B-EU | EUDAMED | IVD General | Active |
| Rapid Diphenoxylate Test | 1L80C3-1-EU, 1L80C3-25-EU, 1L80S3-1-EU, 1L80S3-50-EU | EUDAMED | IVD General | Active |
| Rapid DOA-5 Panel Test | 1L21M3 | EUDAMED | IVD General | Active |
| Rapid Malaria pan Antigen Test Card | 1Q05C2 | EUDAMED | IVD General | Active |
| Thyroid-Globulin Antibody assay (CLIA) | 7B07V1-B-EU, 7B07U1-B-EU, 7B07P1-B-EU | EUDAMED | IVD General | Active |
| Rapid H.Pylori Antibody Test Card | 1O02C2 | EUDAMED | IVD General | Active |
| Rapid HCG Pregnancy Urine Test Card | 1D04C3 | EUDAMED | IVD General | Active |
| Rapid DOA-7 Panel Test Cup (Split type) | 1L23P3 | EUDAMED | IVD General | Active |
| Total Triiodothyronine Test (FIA) | 5B04C1-25-EU, 5B04C1-50-EU | EUDAMED | IVD General | Active |
| Rapid Salmonella typhi/paratyphi Antigen Duo Test | 1O13C2 | EUDAMED | IVD General | Active |
| Rapid DOA-12 Panel Test Card | 1L34C3 | EUDAMED | IVD General | Active |
| Rapid Syphilis Antibody Test Strip | 1N02S2 | EUDAMED | IVD General | Active |
| Rapid EDDP Test Strip | 1L06S3 | EUDAMED | IVD General | Active |
| Rapid THC Test Strip | 1L14S3 | EUDAMED | IVD General | Active |
| Rapid DOA-5 Panel Test Card | 1L21C3 | EUDAMED | IVD General | Active |
| Rapid Kratom Test | 1L72C3-1-EU, 1L72C3-25-EU,1L72S3-1-EU, 1L72S3-50-EU | EUDAMED | IVD General | Active |
| Rapid LH Test Card | 1D02C3 | EUDAMED | IVD General | Active |
| Rapid Syphilis Antibody Test Card | 1N02C2 | EUDAMED | IVD General | Active |
| Rapid Zolpidem Test | 1L83C3-1-EU, 1L83C3-25-EU, 1L83S3-1-EU, 1L83S3-50-EU | EUDAMED | IVD General | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Xiamen Boson Biotech Co., Ltd. US