Singapore HSA registration DE0500995
Bio-Rad Virotrol IV
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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD