Singapore HSA registration DE0501120
Bio-Rad Virotrol HBeAg
Singapore·CLASS B IVD·Bio-Rad Laboratories·Registered January 22, 2018Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD