HSA · registration DE0504769Bio-Rad Lyphochek Specialty Immunoassay Control
SingaporeImmunologyClass CBio-Rad Laboratories Inc.
Official record identity
- Registration number
- DE0504769
- Model name
- Lyphochek Specialty Immunoassay Control Level 1; Lyphochek Specialty Immunoassay Control Level 2; Lyphochek Specialty Immunoassay Control Trilevel MiniPak; Lyphochek Specialty Immunoassay Control Level 3
- Model identifier
- 27124; 27125; 27125X; 27126
- Registration date
- August 04, 2020
- Source update date
- November 18, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Bio-Rad Laboratories Inc.
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Official description
Lyphochek Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes 25-Hydroxy Vitamin D, Procalcitonin, Sex Hormone Binding Globulin (SHBG), Erythropoietin (EPO) and PTH (Intact).
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.