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Bio-Rad InteliQ Diabetes Control - HSA Registration DE0507443

Access comprehensive regulatory information for Bio-Rad InteliQ Diabetes 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 DE0507443 and owned by Bio-Rad Laboratories Inc.. The device was registered on November 01, 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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CLASS B IVD
DE0507443
Bio-Rad InteliQ Diabetes Control
HSA Registration Number: DE0507443
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Product Description

InteliQ Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the Hemoglobin A1c.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0507443
Registration Date
November 01, 2022
Retention Due Date
October 31, 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)
InteliQ Diabetes Control Level 1 InteliQ Diabetes Control Level 2 InteliQ Diabetes Control Level 3 InteliQ Diabetes Control Trilevel MiniPak
Model Identifier(s)
12008309 12008310 12008311 12008312