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ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII QC) QUALITY CONTROL - FDA Registration IVDR-00646B

Access comprehensive regulatory information for ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII QC) QUALITY CONTROL in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00646B and manufactured by Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, USA in USA. The device was registered on November 18, 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.

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USA
IVDR-00646B
ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII QC) QUALITY CONTROL
Registered medical device in Philippines
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Device Information
Product Name
ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII QC) QUALITY CONTROL
Registration Number
IVDR-00646B
Importer & Distribution
Importer/Distributor
Siemens Healthcare Inc.
Registration Dates
Issuance Date
November 18, 2021
Expiry Date
November 18, 2022