Philippines FDA registration IVDR-00343A

Alinity i Anti-HBc II Reagent Kit

Philippines flagPhilippines·Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany·Germany·Issued June 11, 2025 – November 09, 2029
Device information
Product Name
Alinity i Anti-HBc II Reagent Kit
Registration Number
IVDR-00343A
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Abbott Laboratories
Registration dates
Issuance Date
June 11, 2025
Expiry Date
November 09, 2029
About this record

Access comprehensive regulatory information for Alinity i Anti-HBc II Reagent Kit in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00343A and manufactured by Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany in Germany. The device was registered on June 11, 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.

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