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Philippines FDA registration IVDR-00451

ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II CONFIRMATORY (HBsII CONF) ASSAY

PhilippinesSiemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - NY, USAUSAIssued October 20, 2021 – November 29, 2025
VerifiedFDA Philippines · official registry
Device information
Product Name
ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II CONFIRMATORY (HBsII CONF) ASSAY
Registration Number
IVDR-00451
Manufacturer details
Manufacturer
Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - NY, USA
Country of Origin
USA
Importer & distribution
Importer/Distributor
Siemens Healthcare Inc.
Registration dates
Issuance Date
October 20, 2021
Expiry Date
November 29, 2025
About this record

Access comprehensive regulatory information for ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II CONFIRMATORY (HBsII CONF) ASSAY in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00451 and manufactured by Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - NY, USA in USA. The device was registered on October 20, 2021.

This page provides complete registration details including manufacturer information, importer/distributor details (Siemens Healthcare Inc.), 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.