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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ExtendSure | 107253 | FDA UDI | Class I | Active |
| Tosoh US | 997050 | FDA UDI | Class II | Active |
| ExtendSURE | HB610 | FDA UDI | Class II | Active |
| ExtendSURE | HB510 | FDA UDI | Class I | Active |
| Tosoh | 220232 | FDA UDI | Class I | Active |
| Tosoh EU | 997050 | FDA UDI | Class II | Active |
| Extendsure Lyophilized Hba1c Linearity Controls | K071648 | FDA 510(k) | Class I | Active |
| Extendsure Hbfasc Control | K053031 | FDA 510(k) | Class II | Active |
| Liquid Stable Hba1c Control | K043070 | FDA 510(k) | Class I | Active |
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