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Bio-Rad Virotrol IV - HSA Registration DE0500995

Access comprehensive regulatory information for Bio-Rad Virotrol IV 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 DE0500995 and owned by Bio-Rad Laboratories. The device was registered on December 22, 2017.

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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HSA Official Data
CLASS B IVD
DE0500995
Bio-Rad Virotrol IV
HSA Registration Number: DE0500995
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Product Description

Bio-Rad Virotrol IV is intended for use as an unassayed reactive control with in vitro enzyme immunoassay (EIA) procedures for determination of antibodies to Hepatitis B e antigen (anti-HBe). This product is designed for routine for routine use to provide a means of estimating precision and monitoring test system performance

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0500995
Registration Date
December 22, 2017
Retention Due Date
December 21, 2025
Product Owner
Short Name
Bio-Rad
Address
9500 Jeronimo Road, Irvine, California 92618-2017, UNITED STATES, 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 IV
Model Identifier(s)
00111