Singapore HSA registration DE0506479
Bio-Rad InteliQ Urine Chemistry Control
Singapore·CLASS B IVD·Bio-Rad Laboratories, Inc.·Registered December 15, 2021Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD