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Singapore HSA registration DE0504615

Bio-Rad Liquichek Cardiac Troponins Control

Singapore flagSingapore·CLASS C IVD·Bio-Rad Laboratories, Inc·Registered June 19, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0504615
Registration Date
June 19, 2020
Change Notification Approval Date
March 22, 2023
Retention Due Date
June 18, 2025
Product description
Liquichek Cardiac Troponins 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
Name
Bio-Rad Laboratories, Inc
Short Name
Bio-Rad Laboratories, Inc
Address
9500 Jeronimo Road, Irvine, CA 92618-2017, UNITED STATES
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
Liquichek Cardiac Troponins Control Level 1 Liquichek Cardiac Troponins Control Level 1 MiniPak Liquichek Cardiac Troponins Control Level 2 Liquichek Cardiac Troponins Control Level 3 Liquichek Cardiac Troponins Control Level 2 MiniPak Liquichek Cardiac Troponins Control Level 3 MiniPak
Model Identifier(s)
12001084 12001085 12006239 12006369 12006370 12006371
About this record

Access comprehensive regulatory information for Bio-Rad Liquichek Cardiac Troponins 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 DE0504615 and owned by Bio-Rad Laboratories, Inc. The device was registered on June 19, 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