Bioline™ Leptospira - FDA Registration IVDR-00858

Access comprehensive regulatory information for Bioline™ Leptospira in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00858 and manufactured by Abott Diagnostics Korea Inc. (Hagal site) - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyyeonggi do, 17099, Republic of Korea Mfd by: Abott Diagnostics Korea Inc. (Bora site) - 46, Hagal-ro, 15beoin-gil, Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic of Korea in Korea. The device was registered on July 01, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Allied Hospital Supply International Corporation), 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.