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Bio-Rad InteliQ Ethanol/Ammonia Control Levels 1, 2 and 3 - HSA Registration DE0504591

Access comprehensive regulatory information for Bio-Rad InteliQ Ethanol/Ammonia Control Levels 1, 2 and 3 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 DE0504591 and owned by Bio-Rad Laboratories, Inc.. The device was registered on June 12, 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.

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CLASS B IVD
DE0504591
Bio-Rad InteliQ Ethanol/Ammonia Control Levels 1, 2 and 3
HSA Registration Number: DE0504591
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Product Description

InteliQ Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Ammonia and Ethanol.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical toxicology
Registration Information
Registration Number
DE0504591
Registration Date
June 12, 2020
Change Notification Approval Date
April 25, 2025
Retention Due Date
June 11, 2025
Product Owner
Short Name
Bio-Rad Laboratories, Inc.
Address
9500 Jeronimo Road, Irvine, California 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)
InteliQ Ethanol/Ammonia Control Level 1 InteliQ Ethanol/Ammonia Control Level 2 InteliQ Ethanol/Ammonia Control Level 3 InteliQ Ethanol/Ammonia Control MiniPak
Model Identifier(s)
12008299 12008300 12008301 12008302