NEW IN CHINA: QWALYS 3 IS NOW SFDA REGISTERED
The registration certificate for medical device (according to Directive 98/79/EC) certifies that our fully automated system QWALYS 3 has been inspected by the S.F.D.A.’s office (State Food and Drug Administration) and is permitted to register on the Chinese market. This certificate n° 2012-340 1258 is valid for 4 years (until March 14th, 2012).QWALYS® 3 is a machine designed for automating the routine tasks of a clinical diagnosticlaboratory in the field of immunohematology. QWALYS® 3 uses E.M®Technology and QR reagents (Erythrocytes Magnetized Technology) for immunohematology testing. QWALYS® 3 can be used in a variety of tasks, including:
QWALYS® 3 must be used only with in vitro diagnostic medical devices (IVDMDs) from E.M. ®Technology and QR reagents. In order to guarantee the correct and safe use of the machine and to ensure the optimalperformance of all the devices used in it, the instructions given in this manual and in the technicalinserts for the devices used with it absolutely must be followed.
Marketing / Performances of the QWALYS® 3 :
- In market since 2005,
For more information, please contact our Chinese distributor: