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Singapore HSA registration DE0508250

Bio-Rad Access HIV combo V2

Singapore flagSingapore·CLASS D IVD·Bio-Rad France·Registered June 28, 2023
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508250
Registration Date
June 28, 2023
Change Notification Approval Date
March 03, 2025
Retention Due Date
June 27, 2025
Product 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.
Product Owner
Name
Bio-Rad France
Short Name
Bio-Rad France
Address
3 Boulevard Raymond Poincare, 92430 Marnes-la-Coquette, FRANCE
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
Model Name(s)
Access HIV combo V2 Access HIV combo V2 Calibrators Access HIV combo V2 QC Access HIV combo V2 QC plus
Model Identifier(s)
C28430 C28431 C28432 C43576
About this record

Access comprehensive regulatory information for Bio-Rad Access HIV combo V2 in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0508250 and owned by Bio-Rad France. The device was registered on June 28, 2023.

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 D IVD