XinProduct | XinBio CD4+and CD8+ MicroBead Reagents Obtained Class I Medical Device Registration
Date：2023-03-01 Views：
According to 2021 Regulations on the Supervision and Administration of Medical Devices and related laws and regulations, when Class I medical devices are subject to product registration management，a registration certificate or production license is not necessary. The Class I medical device product registration certificate is obtained only after the registration at the local drug supervision and administration department at the city level.
Taking CD4+ Microbeads reagent as an example, the Xinbio independently developed CD4+detection reagent can separate CD4+T cells from fresh or frozen peripheral blood mononuclear cells (PBMCs), white blood cell isolation products, or single-cell suspensions based on CD4 expression on the surface of human cells. The isolated CD4+T cells can be used for cultivation and expansion, flow cytometry, and T cell function testing.
In addition to two product registrations, XinBio has also obtained production registrations. With the support of high-quality R&D and production sites, XinBio will develop more products that meet the requirements of the Regulations on the Supervision and Administration of Medical Devices.
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