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Philippines FDA registration IVDR-00857

Bioline™ Leptospira

PhilippinesAbbott Diagnostics (Hagal site) - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic of Korea Mfd by: Abott Diagnostics Korea Inc. (Bora site) - 46, Hagal-ro, 15beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic of KoreaKoreaIssued July 01, 2025 – July 01, 2030
VerifiedFDA Philippines · official registry
Device information
Product Name
Bioline™ Leptospira
Registration Number
IVDR-00857
Manufacturer details
Manufacturer
Abbott Diagnostics (Hagal site) - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic of Korea Mfd by: Abott Diagnostics Korea Inc. (Bora site) - 46, Hagal-ro, 15beon-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
July 01, 2025
Expiry Date
July 01, 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-00857 and manufactured by Abbott Diagnostics (Hagal site) - 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic of Korea Mfd by: Abott Diagnostics Korea Inc. (Bora site) - 46, Hagal-ro, 15beon-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 (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.