Singapore HSA registration DE0504769
Bio-Rad Lyphochek Specialty Immunoassay Control
Singapore·CLASS C IVD·Bio-Rad Laboratories Inc.·Registered August 04, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0504769
- Registration Date
- August 04, 2020
- Change Notification Approval Date
- November 18, 2024
- Retention Due Date
- August 03, 2025
Product description
Lyphochek Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes 25-Hydroxy Vitamin D, Procalcitonin, Sex Hormone Binding Globulin (SHBG), Erythropoietin (EPO) and PTH (Intact).
Product Owner
- Short Name
- Bio-Rad Laboratories Inc.
- Address
- 9500 Jeronimo Road, Irvine, CA 92618, 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 Specialty Immunoassay Control Level 1 Lyphochek Specialty Immunoassay Control Level 2 Lyphochek Specialty Immunoassay Control Trilevel MiniPak Lyphochek Specialty Immunoassay Control Level 3
- Model Identifier(s)
- 27124 27125 27125X 27126
About this record
Access comprehensive regulatory information for Bio-Rad Lyphochek Specialty Immunoassay Control in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504769 and owned by Bio-Rad Laboratories Inc.. The device was registered on August 04, 2020.
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 C IVD