HSA · registration DE0508250Bio-Rad Access HIV combo V2
SingaporeImmunologyClass DBio-Rad France
Official record identity
- Registration number
- DE0508250
- Model name
- Access HIV combo V2; Access HIV combo V2 Calibrators; Access HIV combo V2 QC; Access HIV combo V2 QC plus
- Model identifier
- C28430; C28431; C28432; C43576
- Registration date
- June 28, 2023
- Source update date
- June 20, 2025
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Bio-Rad France
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Official description
The Access HIV combo V2 assay is a paramagnetic-particle, semi-quantitative chemiluminescent immunoassay (CLIA) for the detection of HIV-1 p24 and HIV-2 p26 antigens and antibodies to HIV-1 and HIV-2 in human serum or plasma using the Access Immunoassay Systems. This assay is intended to be used as an aid in the diagnosis of HIV infection and as a screening tool for blood and plasma donors.
Additional source fields
- Product owner address
- 3 Boulevard Raymond Poincare, 92430 Marnes-la-Coquette, France
- 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.