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HSA · registration DE0507443

Bio-Rad InteliQ Diabetes Control

SingaporeClinical chemistryClass BBio-Rad Laboratories Inc.
Verified
Official record identity
Registration number
DE0507443
Model name
InteliQ Diabetes Control Level 1; InteliQ Diabetes Control Level 2; InteliQ Diabetes Control Level 3; InteliQ Diabetes Control Trilevel MiniPak
Model identifier
12008309; 12008310; 12008311; 12008312
Registration date
November 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 Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the Hemoglobin A1c.

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.