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Bio-Rad InteliQ Specialty Immunoassay Control - HSA Registration DE0505929

Access comprehensive regulatory information for Bio-Rad InteliQ Specialty Immunoassay 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 DE0505929 and owned by Bio-Rad Laboratories Inc.. 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
DE0505929
Bio-Rad InteliQ Specialty Immunoassay Control
HSA Registration Number: DE0505929
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Product Description

InteliQ Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for 25-Hydroxy Vitamin D, Anti-Tg, Anti-Thyroperoxidase (Anti-TPO), C-Peptide, Erythropoietin (EPO), IGF-1/ Somatomedin C, Osteocalcin, PTH (Intact).

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0505929
Registration Date
June 25, 2021
Change Notification Approval Date
April 01, 2022
Retention Due Date
June 24, 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 Speciality Immunoassay Control LTA InteliQ Speciality Immunoassay Control Level 1 InteliQ Speciality Immunoassay Control Level 2 InteliQ Speciality Immunoassay Control Level 3 InteliQ Speciality Immunoassay Control MiniPak
Model Identifier(s)
12008276 12008277 12008278 12008279 12008280