Bio-Rad InteliQ Immunoassay Plus Control
- 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
- Risk class
- Class C
- Product owner
- Bio-Rad Laboratories Inc.
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
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 address
- 9500 Jeronimo Road, Irvine, CA 92618, United States
- Registrant address
- 3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
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.