Philippines FDA registration IVDR-00894

cobas® HCV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems

Philippines flagPhilippines·Roche Molecular System, Inc. – 1080 US Highway 202 South, Branchburg, New Jersey 08876, USA·USA·Issued October 18, 2024 – October 18, 2025
Device information
Product Name
cobas® HCV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
Registration Number
IVDR-00894
Manufacturer details
Country of Origin
USA
Importer & distribution
Importer/Distributor
Roche (Philippines), Inc.
Registration dates
Issuance Date
October 18, 2024
Expiry Date
October 18, 2025
About this record

Access comprehensive regulatory information for cobas® HCV Quantitative nucleic acid test 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-00894 and manufactured by Roche Molecular System, Inc. – 1080 US Highway 202 South, Branchburg, New Jersey 08876, USA in USA. The device was registered on October 18, 2024.

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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