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Bio-Rad Virotrol HBeAg - HSA Registration DE0501120

Access comprehensive regulatory information for Bio-Rad Virotrol HBeAg in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0501120 and owned by Bio-Rad Laboratories. The device was registered on January 22, 2018.

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 B IVD
DE0501120
Bio-Rad Virotrol HBeAg
HSA Registration Number: DE0501120
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Product Description

VIROTROL HBeAg is intended for use as an unassayed reactive control with in vitro assay procedures for the qualitative determination of Hepatitis B e Antigen (HBeAg). This product is designed for routine use to provide a means of estimating precision and monitoring test system performance. This product is not intended for use in conjunction with blood donor screening tests.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0501120
Registration Date
January 22, 2018
Retention Due Date
January 21, 2026
Product Owner
Short Name
Bio-Rad Laboratories
Address
Clinical Diagnostics Group, 9500 Jeronimo Road, Irvine, California 92618-2017, UNITED STATES
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)
Bio-Rad Virotrol HBeAg
Model Identifier(s)
00144