14th July 2017- Snibe Co., Ltd. receives the FDA clearance on the commercialization of TSH on MaglumiTM 2000 fully-automatic chemiluminescence immunoassay system. (US FDA 510 (k), K NO. : K162698) .It is the 1st company in China who received FDA cleared on CLIA product.
The Food and Drug Administration in US (abbreviated in FDA) is the authority for audit international medicine and also the highest executive departments undertaking the regulation of food and medicine under the authorization of the United States federal executive departments. The major way for medical product to get access to USA market is getting the authorization from FDA.
As one of the global pioneers in IVD field, Snibe have always regarded product quality as the foundation of entrepreneur and getting the approval from FDA is a symbol to explain the great endeavor Snibe have put on the way to pursuit high quality products. This achievement not only means Snibe get the tickets to be able to sell in the US market, but the quality of Snibe products portfolio reached the international advanced level and launch a new era to provide more choices for customers as other top companies. More high-quality products of Snibe are continuing to be declared FDA cleared, and it is supposed more good news is coming soon.