Elecsys HBsAg Confirmatory Test Kit - FDA Registration IVDR-00848

Access comprehensive regulatory information for Elecsys HBsAg Confirmatory Test Kit in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00848 and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Manheim, Germany in Germany. The device was registered on April 22, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Roche (Philippines) Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.