Singapore HSA registration DE0507176
Bio-Rad InteliQ Immunoassay Plus Control
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0507176
- Registration Date
- August 19, 2022
- Change Notification Approval Date
- March 21, 2024
- Retention Due Date
- August 18, 2025
Product description
InteliQ Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (Acetaminophen, AFP, Amikacin, Androstenedione, Caffeine, Carbamazepine, CEA, CK-MB Isoenzyme, Cortisol, Dehydroepiandrosterone-Sulfate, Digoxin, Estradiol, Estriol (Free), Ferritin, Folate, Follicle Stimulating Hormone, Gentamicin, hCG, Human Growth Hormone, Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Insulin, Iron, Lidocaine, Lithium, Luteinizing Hormone, N-Acetyl Procainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Progesterone, Prolactin, PSA (Free), PSA (Total), Quinidine, Salicylate, Sex Hormone Binding Globulin, T3 (Free), T3 (Total), T3 Uptake/T Uptake, T4 (Free), T4 (Total), Testosterone, Theophylline, Thyroid Stimulating Hormone, Thyroxine Binding Globulin, Tobramycin, Tricyclic Antidepressants, Valproic acid, Vancomycin, and Vitamin B12)
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 Immunoassay Plus Control Level 1 InteliQ Immunoassay Plus Control Level 2 InteliQ Immunoassay Plus Control Level 3 InteliQ Immunoassay Plus Trilevel MiniPak
- Model Identifier(s)
- 12009948 12009949 12009950 12009951
About this record
Access comprehensive regulatory information for Bio-Rad InteliQ Immunoassay Plus 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 DE0507176 and owned by Bio-Rad Laboratories Inc.. The device was registered on August 19, 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