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Bio-Rad Platelia Measles IgM Assay - HSA Registration DE0013883

Access comprehensive regulatory information for Bio-Rad Platelia Measles IgM Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0013883 and owned by Bio-Rad. The device was registered on September 20, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C IVD
DE0013883
Bio-Rad Platelia Measles IgM Assay
HSA Registration Number: DE0013883
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Product Description

Bio-Rad Platelia Measles IgM uses immunoenzymatic capture method for the qualitative determination of IgM-Class antibodies to Measles virus in human serum.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDC00106
HS Code
38220090
Registration Information
Registration Number
DE0013883
Registration Date
September 20, 2013
Change Notification Approval Date
May 17, 2024
Retention Due Date
September 19, 2025
Product Owner
Short Name
Bio-Rad
Address
3, bvd Raymond Poincare, 92430 Marnes-La-Coquette, FRANCE
Registrant
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model Information
Model Name(s)
Platelia Measles IgM Assay (48 tests)
Model Identifier(s)
72687