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Bio-Rad InteliQ Immunology Control - HSA Registration DE0506951

Access comprehensive regulatory information for Bio-Rad InteliQ Immunology Control 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 DE0506951 and owned by Bio-Rad Laboratories. The device was registered on June 14, 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 C IVD
DE0506951
Bio-Rad InteliQ Immunology Control
HSA Registration Number: DE0506951
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Product Description

InteliQ Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for ADNase B (Antideoxyribonuclease-B), Albumin, Alpha 1-Antitrypsin, Alpha 2-Macroglobulin, Alpha-1-Acid Glycoprotein, Anti-cyclic Citrullinated Peptide (Anti-CCP), Antistreptolysin-O, Antithrombin III (AT III), Apolipoprotein A-I, Apolipoprotein B, Beta-2-Microglobulin, C1 Inhibitor, Ceruloplasmin, Complement C3, Complement C4, C-Reactive Protein (CRP), Cystatin C, Ferritin, Haptoglobin, IgG Subclass I, IgG Subclass 2, IgG Subclass 3, IgG Subclass 4, Immunoglobulin A (IgA), Immunoglobulin E (IgE), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Kappa Light Chain, Lambda Light Chain, Lipoprotein (a), Prealbumin, Properdin Factor B, Protein Serum (Total), Retinol Binding Protein (RBP), Rheumatoid Factor, Transferrin.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0506951
Registration Date
June 14, 2022
Change Notification Approval Date
March 13, 2025
Retention Due Date
June 13, 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 Immunology Control Level 1 InteliQ Immunology Control Level 2 InteliQ Immunology Control Level 3 InteliQ Immunology Control Trilevel MiniPak
Model Identifier(s)
12009941 12009942 12009943 12009944