Philippines FDA registration IVDR-00961

cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test kit for use on the cobas® 5800/6800/8800 Systems

Philippines flagPhilippines·Roche Molecular Systems, Inc.·USA·Issued April 25, 2025 – April 25, 2030
Device information
Product Name
cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test kit for use on the cobas® 5800/6800/8800 Systems
Registration Number
IVDR-00961
Manufacturer details
Country of Origin
USA
Importer & distribution
Importer/Distributor
Roche (Philippines), Inc.
Registration dates
Issuance Date
April 25, 2025
Expiry Date
April 25, 2030
About this record

Access comprehensive regulatory information for cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test kit for use on the cobas® 5800/6800/8800 Systems in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00961 and manufactured by Roche Molecular Systems, Inc. in USA. The device was registered on April 25, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Roche (Philippines), 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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