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HSA · registration DE0505202

Bio-Rad qUAntify Advance Control

SingaporeClinical chemistryClass BBio-Rad Laboratories Inc.
Verified
Official record identity
Registration number
DE0505202
Model name
qUAntify Advance Control, Bilevel; qUAntify Advance Control, Bilevel MiniPak
Model identifier
12007028; 12007029
Registration date
December 04, 2020
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

qUAntify Advance Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.

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.