Universal Biosensors, Inc. announced that it has submitted its 510K application to the US Food & Drug Administration (FDA) to have Xprecia Prime approved for sale in the USA. The centrepiece of the 510K application is the 360 patient study (com completed 23 January, 2023) conducted over 4 sites in the USA which is designed to provide clinical evidence as to the performance and safety of Xprecia Prime.
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5-day change | 1st Jan Change | ||
0.13 AUD | -3.70% | 0.00% | -35.00% |
May. 08 | Universal Biosensors Raises AU$10 Million via Entitlement Offer | MT |
May. 02 | Universal Biosensors Narrows Q1 Loss as Revenue Rises; Shares Fall 3% | MT |
Annual profits - Rate of surprise
1st Jan change | Capi. | |
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-35.00% | 20.86M | |
+11.18% | 227B | |
+15.22% | 198B | |
+19.19% | 142B | |
+30.89% | 111B | |
+1.56% | 64.16B | |
+18.48% | 54.1B | |
+5.12% | 51.41B | |
+10.53% | 45.32B | |
+5.98% | 37.32B |
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- Universal Biosensors, Inc. Submits Xprecia Prime 510K Application to US Food & Drug Administration