Philippines FDA registration IVDR-00197A

BioClone® Anti-IgG, -C3D Polyspecific In Vitro Diagnostic Reagent

Philippines flagPhilippines·Ortho-Clinical Diagnostics Pencoed, Brigend, United Kingdom Mfd. By: Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202, Raritan NJ 08869, USA·United Kingdom·Issued October 07, 2022 – April 05, 2027
Device information
Product Name
BioClone® Anti-IgG, -C3D Polyspecific In Vitro Diagnostic Reagent
Registration Number
IVDR-00197A
Manufacturer details
Country of Origin
United Kingdom
Importer & distribution
Registration dates
Issuance Date
October 07, 2022
Expiry Date
April 05, 2027
About this record

Access comprehensive regulatory information for BioClone® Anti-IgG, -C3D Polyspecific In Vitro Diagnostic Reagent in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00197A and manufactured by Ortho-Clinical Diagnostics Pencoed, Brigend, United Kingdom Mfd. By: Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202, Raritan NJ 08869, USA in United Kingdom. The device was registered on October 07, 2022.

This page provides complete registration details including manufacturer information, importer/distributor details (Ortho-Clinical Diagnostics 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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