Our Certifications

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DiviTum®TKa has received a FDA 510(k) clearance in the US

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DiviTum®TKa is CE marked according to IVDD and the transitional provisions in Article 110, IVDR 2017/746

Biovica’s development, production, and distribution facility is certified according to ISO 13485:2016.

Medical Device Single Audit Program (MDSAP) U.S. certificate

Biovica's laboratory is CLIA certified

Biovica’s laboratory in San Diego, CA has received CLIA certification.

>4,500

Numbers of patients in studies

28

Publications

19

Pharma Projects

Are you a US resident?

Only US residents will be able to qualify for this program

No