KeyGEN diagnostic reagent products focus on the fields of gynecology and reproduction, cardio-cerebrovascular, inflammatory infection and kidney disease, and have obtained dozens of product registration certificates.
On the basis of the existing routine testing projects, the company's R&D team actively innovated and developed new gynecological and obstetric tests including sFlt-1/PIGF Detection Kit and anti-Müllerian hormone test kit (AMH Detection Kit). Pregnancy POCT products are mainly used for pregnancy detection and early detection of population eugenics. With the adjustment of the national family planning policy, the market for POCT products for pregnancy is huge.
keyGEN Diagnostics has an in vitro diagnostic CMO platform, and has established a high-quality management system that meets the requirements of "Medical Device Manufacturing Quality Management Standards" and ISO13485 "Medical Device Quality Management System", with a construction area of 2,800 square meters. , including 100,000-level clean area, quality inspection area, 10,000-level environmental testing laboratory, low-temperature cold storage and other experimental production sites, for enterprises and their cooperative customers to carry out the design, development, production, and quality management of clinical analytical instruments and in vitro diagnostic reagents. Aside from that, KeyGEN also provides registration consulting, large-scale production, marketing and other services.
In the future, Keygen Diagnostics will add multiple products and become one of the company with the most complete POCT product line in the fields of gynecology and reproduction, cardiovascular and cerebrovascular diseases, inflammatory infections, and kidney diseases，and continue to be committed to innovative research and development, to create a leading enterprise in domestic diagnostic reagents!