This page includes the latest FDA filings for Universal Biosensors Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3007057632 |
| FEI Number | 3007057632 |
| Name | Michael Van de Woude |
| Owner & Operator | Universal Biosensors Pty Ltd |
| Contact Address | 1 Corporate Avenue Rovwille AU-VIC Victoria 3178 AU |
| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2500 Bee Cave Road Bldg 1, Suite 300 Austin, TX 78746 US |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
Device Company | Device | Date |
|---|---|---|
| UNIVERSAL BIOSENSORS PTY LTD | Xprecia Prime™ PT/INR Test Strips 30106 | 2024-09-04 |
| UNIVERSAL BIOSENSORS PTY LTD | Xprecia Prime™ Coagulation Analyzer 90306 | 2024-09-04 |
| UNIVERSAL BIOSENSORS PTY LTD | Xprecia™ Systems PT Controls 90506 | 2024-09-04 |
Michael Van de Woude [Universal Biosensors Pty Ltd] | Xprecia Systems PT/INR Strips | 2016-10-20 |
Michael Van de Woude [Universal Biosensors Pty Ltd] | Xprecia Systems PT/INR Strips | 2016-10-20 |