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HSA · registration DE0507176

Bio-Rad InteliQ Immunoassay Plus Control

SingaporeImmunologyClass CBio-Rad Laboratories Inc.
Official record identity
Registration number
DE0507176
Model name
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
12009948; 12009949; 12009950; 12009951
Registration date
August 19, 2022
Source update date
March 21, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Immunology
Published parties
Registrant / registration holder
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Official 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)

Additional source fields
Product owner address
9500 Jeronimo Road, Irvine, CA 92618, United States
Registrant address
3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.