Singapore HSA registration DE0503677
Bio-Rad Lyphochek Allergen slgE Control
Singapore·CLASS B IVD·Bio-Rad Laboratories·Registered October 01, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0503677
- Registration Date
- October 01, 2019
- Retention Due Date
- September 30, 2025
Product description
Lyphochek Allergen slgE Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
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)
- Lyphochek Allergen sIgE Control, Negative Lyphochek Allergen sIgE Control, Panel A Lyphochek Allergen sIgE Control, Negative (MiniPak) Lyphochek Allergen sIgE Control, Panel A (MiniPak)
- Model Identifier(s)
- 12000141 12000142 12000143 12000144
About this record
Access comprehensive regulatory information for Bio-Rad Lyphochek Allergen slgE Control 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 DE0503677 and owned by Bio-Rad Laboratories. The device was registered on October 01, 2019.
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