AUTOGENOMICS, INCORPORATED

9 devices 10 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ AU (TGA)
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Devices

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Device Name US UK CA AU EU
AvertD and AvertD Buccal Sample Collection Kit Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI ANALYZER Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI CYP2C19 ASSAY Registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI SYSTEM Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI SYSTEM - ANALYZER Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI SYSTEM - CYP2C19 ASSAY Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI SYSTEM - WARFARIN (CYP2C9-VKORC1) ASSAY Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
INFINITI WARFARIN ASSAY Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)

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