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Philippines FDA registration IVDR-00863

Bioline™ Leptospira

PhilippinesAbott 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 KoreaKoreaIssued May 13, 2025 – June 14, 2030
VerifiedFDA Philippines · official registry
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.