Pure Global

Bio-Rad Anti-Dia (DI1) - HSA Registration DE0508663

Access comprehensive regulatory information for Bio-Rad Anti-Dia (DI1) 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 DE0508663 and owned by Bio-Rad Medical Diagnostics GmbH. The device was registered on November 14, 2023.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0508663
Bio-Rad Anti-Dia (DI1)
HSA Registration Number: DE0508663
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Coombsreactive Antisera are polyclonal reagents for the determination of red blood cell antigens of different blood type systems: Diego-system (Dia). They are suited for the performance of an indirect antiglobulin-test in the test tubes.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0508663
Registration Date
November 14, 2023
Change Notification Approval Date
January 27, 2025
Retention Due Date
November 13, 2025
Product Owner
Short Name
Bio-Rad Medical Diagnostics GmbH
Address
Industriestr. 1, D-63303, Dreieich, GERMANY
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)
Anti-Dia (DI1)
Model Identifier(s)
808270