Singapore HSA registration DE0506951
Bio-Rad InteliQ Immunology Control
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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD