Atlas Link Technology Co., Ltd
As a manufacturer and supplier of in-vitro diagnostic (IVD) test kits, while providing our best rapid test kits and ELISA kits world widely, Atlas Link Technology Co., Ltd keeps on making improvement, especially on the production facility, R&D laboratory and international certification.
Production Facility of IVD Test Kits
Atlas Link Technology Co., Ltd owns a professional product facility for various In-Vitro Diagnostic (IVD) test kits. Our current factory comprises of a production area measures 1500 M2, which was built according to GMP standards; and the warehouse measures 3000 M2 for the storage of materials and finished products; our manufacturing protocols are designed strictly according to the guidelines of ISO13485:2006.
Factory Expansion Plan (Phase II) has been constructed; and will be put in use soon after the final assessment by local authority. According to this plan, we will expend the current plant significantly, and the core construction is a total automatic, super-clean GMP industrial plant, which meets the standards for the production of the III Category medical devices. After put in use, our annual production capacity of IVD test kits will exceed 100 Million tests, and Atlas Link Technology Co., Ltd will become one of the biggest manufacturers of IVD rapid test kits in China.
R&D Laboratory of Atlas Link
In IVD test kit realm, upgrading and new product launching are important in order to provide most needed products to the market. To meet this natural requirement, Beta-Bear laboratory, the R&D department of Atlas Link Technology Co., Ltd was established.
This bio-laboratory is supported by 3 professors and 8 associate professors; and we have established long-term cooperation with several famous universities; equipped most advanced research equipment, like Ultra-micro ultraviolet spectrophotometer, Ultra high speed refrigerated centrifuge, 3D colloidal gold spraying instrument. Its functions include:
- Research and development of new IVD test kits;
- Quality benchmarking and proofing of diagnostic test kits;
- Provide total solution for customers who have special testing requirements;
- Guide and supervise the production procedures of Atlas Link factory;
- Testing and proofing service to other IVD manufacturers.
The production and design facilities of Atlas Link Technology Co., Ltd are TUV ISO13485:2016 certified.
We have applied and will keep on applying for certification such as CE and FDA for our IVD test kits. For example, we have got CE certificate issued by TUV for LH urine test kits, HCG urine test kits and FOB test kits; CE certification for all the series of COIVD-19 rapid test kits; CE Certificate issued by 3EC for three serum test kits of HBsAg, anti-HCV and anti-HIV 1/2.
For all of SARS-COV-2 test kits (antigen or antibodies; blood or swab specimens), after putting into market, we submitted technical document to the EU notified body TUV, and have got the permission to print CE mark on all these test kits, and are selling to EU professional market ever since. Some of these certificates are provided below:
- ISO 13485:2006 (No. Q5 057995 0012 Rev.01)
- TUV CE (No. V1 057995 0009 Rev.02)
- 3EC CE (No. 2020-IVD/QS-004)
(All IFUs, Certificates and other documents provided in the website are for exhibition purpose only; for pratical use, please check with your sales manager for the final and current versions.)
General Information of Atlas Link
Atlas Link Technology Co., Ltd, an ISO13485:2016 certified company, is a professional manufacturer and supplier of various in-vitro diagnostic (IVD) test kits, including lateral flow rapid test kits, ELISA kits and enzyme reaction test kits. Our customers come from more than 100 countries.
Our headquarter and sales facility is located in Shijingshan Dist. of Beijing city; and production facility is located in Hebei Province, near the southern border of Beijing; and a R&D bio-technical laboratory in Daxing Dist., Beijing.
We are committed to supply IVD test kits to make in-vitro diagnosis simpler, faster, more reliable and more affordable. Our mission is to provide quality products that meet each customer's specific requirements in a timely manner.