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HSA · registration DE0506892

Bio-Rad InteliQ Tumor Marker Control

SingaporeClinical chemistryClass CBio-Rad Laboratories Inc.
Verified
Official record identity
Registration number
DE0506892
Model name
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
12008289; 12008290; 12008291; 12008292
Registration date
May 26, 2022
Source update date
March 21, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Clinical chemistry
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Published parties
Product owner
Bio-Rad Laboratories Inc.
Registrant / registration holder
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Official 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).

Additional source fields
Product owner address
9500 Jeronimo Road, Irvine, CA 92618, United States
Registrant address
3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.