Philippines FDA registration IVDR-00835

cobas® HIV-1 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 April 22, 2025 – May 28, 2030
Device information
Product Name
cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
Registration Number
IVDR-00835
Manufacturer details
Country of Origin
USA
Importer & distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration dates
Issuance Date
April 22, 2025
Expiry Date
May 28, 2030
About this record

Access comprehensive regulatory information for cobas® HIV-1 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-00835 and manufactured by Roche Molecular System Inc. - 1080 US Highway 202 South Branchburg, New Jersey 08876, USA in USA. The device was registered on April 22, 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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