HemaXis DB is a FDA Class 1 medical device. HemaXis DX is in development and for research purposes only. Use of HemaXis devices in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with local regulatory requirements.
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DBS System SA
Rte des Avouillons 4
Tel: +41 (0) 78 624 70 15