Philippines FDA registration IVDR-00863

Bioline™ Leptospira

Philippines·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·Korea·Issued May 13, 2025 – June 14, 2030

Device information

Product Name: Bioline™ Leptospira
Registration Number: IVDR-00863

Manufacturer details

Manufacturer: 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
Country of Origin: Korea

Importer & distribution

Importer/Distributor: Abbott Laboratories

Registration dates

Issuance Date: May 13, 2025
Expiry Date: June 14, 2030

About this record

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-00863 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 May 13, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Abbott Laboratories), 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.