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Boson
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Company Overview

Xiamen Boson Biotech Co., Ltd., as a specialist of in vitro diagnostic kits field was founded in
2001, we develop and manufacture high-quality point of care and other immunoassay kits for
world-wide market.
Our 10,000 square meter facility is operated strictly under ISO 13485:2016 and GMP guidelines.
Our product lines provide the immunoassays in various formats to detect cardiac markers,
drugs of abuse, fertility hormones, infectious diseases, tumor markers and animal diseases.
Many of our products have been approved by NMPA and CE.
Our company presents its product with well-designed Boson and HomeScan packaging. We also
provide OEM and private label service for customers.
Xiamen Boson Biotech’s mission is to provide the affordable high-quality products to help fight
diseases and illicit substance abuse

Certificates

CE

CE

Description

The Certification Body of TUV SOD Product Service GmbH declares that a design examination has been carTed out on the respective devices in accordance with IVDD AnnexIll (6)The desian of the devices conforms to the requirements of this Directive. All applicable requirements of the testing and certification regulation of TUV SOD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=certV9 061317 0006 Rev.00

Declaration of Conformity

Declaration of Conformity

Description

We herewith declare that above mentioned products meet the provisions of the council Directive 98/79/EC for medical devices.All Supporting Documentation is Retained under the premises of the manufacturer. We have sole responsibility for issuing the Declaration of Conformity.
 Rapid SARS-CoV-2 Antigen Test Card, REF:1N40C5-2 Rapid SARS-CoV-2 Antigen Test Card,REF:1N40C5-4 Rapid SARS-CoV-2 Antigen Test Card, REF:1N40C5-6

ISO 13485 Certificate

ISO 13485 Certificate

Description

The Cerification Body of TUV SUD Product Service GmbH certifies that the company mentlioned above Fas establishod and is naintainins a guality management system.which meets the requirements of the listed standard(s). See also notes overleatl.

Company Information

Business Type Manufacturer, Trading Company, Distributor/Wholesaler
Company Boson
Main Products covid-19 antigen rapid test
Website www.bosonbio.com
Established Year 2001
City / State Xiamen , Fujian
Country China
Address

Factory Information

Location Xiamen, China
Factory Size 10,000 square meter
Total QC Staff 100
Total RND Staff 20
Number of Production Lines 10
Annual output
Average Lead Time

Trading Information

Total Revenue
Export Percentage
Nearest Port Xiamen
Overseas Office
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