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Bio-Rad InteliQ Immunoassay Plus Control - HSA Registration DE0507176

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.

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CLASS C IVD
DE0507176
Bio-Rad InteliQ Immunoassay Plus Control
HSA Registration Number: DE0507176
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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)

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 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