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Singapore HSA registration DE0506892

Bio-Rad InteliQ Tumor Marker Control

Singapore flagSingapore·CLASS C IVD·Bio-Rad Laboratories Inc.·Registered May 26, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0506892
Registration Date
May 26, 2022
Change Notification Approval Date
March 21, 2024
Retention Due Date
May 25, 2025
Product description
InteliQ Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (AFP, Beta-2- Microglobulin, CA 125, CA15-3, CA 19-9, CA 27.29, CA 72-4, CEA, Cyfra 21-1, Ferritin, hCG, HE4 (Human Epididymis Protein 4, HER-2/neu, IFG- 1/Somatomedin C, ProGRP (Progastrin-Releasing Peptide), Prolactin, Prostatic Acid Phosphatase (PAP), PSA (Free), PSA (Total), Squamous Cell Carcinoma(SCC) and Thyroglobulin).
Product Owner
Name
Bio-Rad Laboratories Inc.
Short Name
Bio-Rad Laboratories Inc.
Address
9500 Jeronimo Road, Irvine, CA 92618, UNITED STATES
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
InteliQ Tumor Marker Control Level 1 InteliQ Tumor Marker Control Level 2 InteliQ Tumor Marker Control Level 3 InteliQ Tumor Marker Control Trilevel MiniPak
Model Identifier(s)
12008289 12008290 12008291 12008292
About this record

Access comprehensive regulatory information for Bio-Rad InteliQ Tumor Marker Control in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506892 and owned by Bio-Rad Laboratories Inc.. The device was registered on May 26, 2022.

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 C IVD