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Philippines FDA registration IVDR-00992

Alinity i HBsAg Qualitative II Confirmatory Reagent Kit

PhilippinesAbbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, IrelandIrelandIssued July 01, 2025 – July 01, 2026
VerifiedFDA Philippines · official registry
Device information
Product Name
Alinity i HBsAg Qualitative II Confirmatory Reagent Kit
Registration Number
IVDR-00992
Manufacturer details
Country of Origin
Ireland
Importer & distribution
Importer/Distributor
Abbott Laboratories
Registration dates
Issuance Date
July 01, 2025
Expiry Date
July 01, 2026
About this record

Access comprehensive regulatory information for Alinity i HBsAg Qualitative II Confirmatory Reagent Kit in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00992 and manufactured by Abbott Ireland Diagnostics Division - Finisklin Business Park, Sligo, Ireland in Ireland. 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.