Philippines FDA registration IVDR-00960

Cobas ® MPX Control Kit Multiplex HIV, HCV & HBV Nucleic Acid Test Control Kit for use on cobas ® 5800/6800/8800 Systems

Philippines flagPhilippines·Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg NewJersey, 08876, USA·USA·Issued June 10, 2025 – June 10, 2026
Device information
Product Name
Cobas ® MPX Control Kit Multiplex HIV, HCV & HBV Nucleic Acid Test Control Kit for use on cobas ® 5800/6800/8800 Systems
Registration Number
IVDR-00960
Manufacturer details
Country of Origin
USA
Importer & distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration dates
Issuance Date
June 10, 2025
Expiry Date
June 10, 2026
About this record

Access comprehensive regulatory information for Cobas ® MPX Control Kit Multiplex HIV, HCV & HBV Nucleic Acid Test Control Kit for use on 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-00960 and manufactured by Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg NewJersey, 08876, USA in USA. The device was registered on June 10, 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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