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Bio-Rad InteliQ Urine Chemistry Control - HSA Registration DE0506479

Access comprehensive regulatory information for Bio-Rad InteliQ Urine Chemistry 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 DE0506479 and owned by Bio-Rad Laboratories, Inc.. The device was registered on December 15, 2021.

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
DE0506479
Bio-Rad InteliQ Urine Chemistry Control
HSA Registration Number: DE0506479
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Product Description

InteliQ Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, Magnesium, Microalbumin, Osmolality, pH, Phosphorous, Potassium, Pregnancy/hCG (Qualitative), Protein (Total), Sodium, Specific Gravity, Urea, Urea Nitrogen (BUN), Uric Acid.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0506479
Registration Date
December 15, 2021
Change Notification Approval Date
September 27, 2022
Retention Due Date
December 14, 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)
InteliQ Urine Chemistry Control, Level 1 InteliQ Urine Chemistry Control, Level 2 InteliQ Urine Chemistry Control, Bilevel MiniPak
Model Identifier(s)
12009995 12009996 12009997