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Bio-Rad qUAntify Advance Control - HSA Registration DE0505202

Access comprehensive regulatory information for Bio-Rad qUAntify Advance Control in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0505202 and owned by Bio-Rad Laboratories Inc.. The device was registered on December 04, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B IVD
DE0505202
Bio-Rad qUAntify Advance Control
HSA Registration Number: DE0505202
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Product 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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0505202
Registration Date
December 04, 2020
Retention Due Date
December 03, 2025
Product Owner
Short Name
Bio-Rad Laboratories Inc.
Address
9500 Jeronimo Road, Irvine, CA 92618, UNITED STATES
Registrant
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model Information
Model Name(s)
qUAntify Advance Control, Bilevel qUAntify Advance Control, Bilevel MiniPak
Model Identifier(s)
12007028 12007029