Singapore HSA registration DE0505929
Bio-Rad InteliQ Specialty Immunoassay Control
Singapore·CLASS B IVD·Bio-Rad Laboratories Inc.·Registered June 25, 2021Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0505929
- Registration Date
- June 25, 2021
- Change Notification Approval Date
- April 01, 2022
- Retention Due Date
- June 24, 2025
Product description
InteliQ Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for 25-Hydroxy Vitamin D, Anti-Tg, Anti-Thyroperoxidase (Anti-TPO), C-Peptide, Erythropoietin (EPO), IGF-1/ Somatomedin C, Osteocalcin, PTH (Intact).
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 Speciality Immunoassay Control LTA InteliQ Speciality Immunoassay Control Level 1 InteliQ Speciality Immunoassay Control Level 2 InteliQ Speciality Immunoassay Control Level 3 InteliQ Speciality Immunoassay Control MiniPak
- Model Identifier(s)
- 12008276 12008277 12008278 12008279 12008280
About this record
Access comprehensive regulatory information for Bio-Rad InteliQ Specialty Immunoassay 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 DE0505929 and owned by Bio-Rad Laboratories Inc.. The device was registered on June 25, 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