OEM Manufacturing

ISO 13485-certified manufacturing with scalable production capabilities and consistent quality standards. Reliable OEM production and stable large-scale manufacturing capacity.

ISO 13485

01

ISO 13485​

Our manufacturing infrastructure is designed to support a wide range of production volumes, from initial pilot batches to high-volume commercial output. Processes are standardized and optimized to allow smooth scale-up without compromising performance or efficiency. This enables partners to transition from early market entry to large-scale distribution within the same production framework.

02

Scalable production​

All assays are developed based on established lateral flow immunoassay technologies with demonstrated performance and stability. The product portfolio has been refined through continuous production and market use, ensuring reproducibility and reliability across batches. Existing validation data and real-world application provide a solid foundation for partners seeking dependable diagnostic solutions.

03

Consistent quality

Quality is ensured through controlled processes, standardized operating procedures, and defined in-process and final inspections. Each production stage is monitored to maintain uniformity, minimizing variability between batches. This approach ensures reliable assay performance and stability, meeting both internal specifications and customer requirements across all delivered products.

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Shenzhen Kang Sheng Bao
Biotechnology Co., Ltd.

Second Floor, Block 3, Anda

Electronic Industrial Park,

Fuhai, Bao’an District,

518103 Shenzhen, 

Guangdong Province, PRC

 

+86 0755 27417763 

 

info@ksbbiotech.com