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HSA · registration DE0505929

Bio-Rad InteliQ Specialty Immunoassay Control

SingaporeClinical chemistryClass BBio-Rad Laboratories Inc.
Verified
Official record identity
Registration number
DE0505929
Model name
InteliQ Speciality Immunoassay Control LTA; InteliQ Speciality Immunoassay Control Level 1; InteliQ Speciality Immunoassay Control Level 2; InteliQ Speciality Immunoassay Control Level 3; InteliQ Speciality Immunoassay Control MiniPak
Model identifier
12008276; 12008277; 12008278; 12008279; 12008280
Registration date
June 25, 2021
Source update date
April 01, 2022
Classification
Risk class
Class B
Official value: CLASS B
Published category
Clinical chemistry
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Published parties
Product owner
Bio-Rad Laboratories Inc.
Registrant / registration holder
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Official description

InteliQ Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for 25-Hydroxy Vitamin D, Anti-Tg, Anti-Thyroperoxidase (Anti-TPO), C-Peptide, Erythropoietin (EPO), IGF-1/ Somatomedin C, Osteocalcin, PTH (Intact).

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.