Philippines FDA registration IVDR-00343B

Alinity i Anti-HBc II Calibrator

Name: Alinity i Anti-HBc II Calibrator — Philippines FDA registration IVDR-00343B
Creator: Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany
Keywords: Alinity i Anti-HBc II Calibrator, IVDR-00343B, Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany, Abbott Laboratories, Germany, Philippines FDA registration

PhilippinesAbott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, GermanyGermanyIssued June 11, 2025 – November 09, 2029

VerifiedFDA Philippines · official registry

Device information

Product Name: Alinity i Anti-HBc II Calibrator
Registration Number: IVDR-00343B

Manufacturer details

Manufacturer: Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany
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 Calibrator in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00343B 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.