Pure Global

Bio-Rad Lyphochek Specialty Immunoassay Control - HSA Registration DE0504769

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0504769
Bio-Rad Lyphochek Specialty Immunoassay Control
HSA Registration Number: DE0504769
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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).

Device 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 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