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Singapore HSA registration DE0506867

Bio-Rad InteliQ Cardiac Markers Plus Control LT

Singapore flagSingapore·CLASS C IVD·Bio-Rad Laboratories·Registered May 17, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0506867
Registration Date
May 17, 2022
Change Notification Approval Date
November 01, 2022
Retention Due Date
May 16, 2025
Product description
InteliQ Cardiac Markers Plus Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert:- B-type Natriuretic Peptide (BNP), CK-MB Isoenzyme, C-Reactive Protein (CRP), Creatine Kinase (CK), Digitoxin, Myoglobin, N-terminal pro-Brain Natriuretic Peptide (NT-proBNP), Troponin I & Troponin T.
Product Owner
Name
Bio-Rad Laboratories
Short Name
Bio-Rad Laboratories
Address
9500 Jeronimo Road, Irvine, California 92618, 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)
InteliQ Cardiac Markers Plus Control LT, Level 1 InteliQ Cardiac Markers Plus Control LT, Level 2 InteliQ Cardiac Markers Plus Control LT, Level 3 InteliQ Cardiac Markers Plus Control LT, Level 1A InteliQ Cardiac Markers Plus Control LT, Level 1B InteliQ Cardiac Markers Plus Control LT, Level 1C InteliQ Cardiac Markers Plus Control LT, Level 1 MiniPak InteliQ Cardiac Markers Plus Control LT, Level 2 MiniPak InteliQ Cardiac Markers Plus Control LT, Level 3 MiniPak InteliQ Cardiac Markers Plus Control LT, Level 1A MiniPak InteliQ Cardiac Markers Plus Control LT, Level 1B MiniPak InteliQ Cardiac Markers Plus Control LT, Level 1C MiniPak
Model Identifier(s)
12009955 12009956 12009957 12009958 12009959 12009960 12009961 12009962 12009963 12009964 12009965 12009966
About this record

Access comprehensive regulatory information for Bio-Rad InteliQ Cardiac Markers Plus Control LT 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 DE0506867 and owned by Bio-Rad Laboratories. The device was registered on May 17, 2022.

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.

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