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Bio-Rad InteliQ Homocysteine Control - HSA Registration DE0505928

Access comprehensive regulatory information for Bio-Rad InteliQ Homocysteine Control 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 DE0505928 and owned by Bio-Rad Laboratories. The device was registered on June 25, 2021.

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
DE0505928
Bio-Rad InteliQ Homocysteine Control
HSA Registration Number: DE0505928
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Product Description

InteliQ Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0505928
Registration Date
June 25, 2021
Retention Due Date
June 24, 2025
Product Owner
Short Name
Bio-Rad Laboratories
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 Homocysteine Control Level 1 InteliQ Homocysteine Control Level 2 InteliQ Homocysteine Control Level 3 InteliQ Homocysteine Control Minipak
Model Identifier(s)
12004309 12004310 12004311 12004312