Our product receives the Registration Certificate for Medical Device by the SFDA
Vircell is delighted to announce that the competent authority of the People’s Republic of China has granted the Registration Certificate for Medical Device to our product PNEUMOSLIDE IgM for 4 years.
Since February 2010, PNEUMOSLIDE IgM has the SFDA Approval (State Food and Drug Administration, P.R. China) to be commercialized in the Chinese market. This great achievement has been possible due to the invaluable collaboration of our exclusive distributor in China, Autobio Diagnostics Co. Ltd, and in particular to their whole technical and commercial team. After several years of relationship, this fact means a milestone in our commercial cooperation, which we hope to consolidate in the next years.
PNEUMOSLIDE IgM is a multitest immunofluorescence kit for the simultaneous detection of the bacteria and viruses most frequently associated with human respiratory infections.
The introduction of this product in the Chinese market will contribute to reinforcing the global presence of Vircell. We truly hope to increase our products´ presence in the Chinese clinical diagnostic market.