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Singapore HSA registration DE0504581

Bio-Rad BioPlex 2200 HIV Ag-Ab

Singapore flagSingapore·CLASS D IVD·Bio-Rad Laboratories, Inc.·Registered June 10, 2020
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0504581
Registration Date
June 10, 2020
Change Notification Approval Date
August 28, 2024
Retention Due Date
June 09, 2025
Product description
The BioPlex 2200 HIV Ag-Ab assay is a multiplex flow immunoassay intended for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen, antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma. This kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute or primary HIV-1 infection. The BioPlex 2200 HIV Ag-Ab assay can also be used to screen blood and plasma donors. The BioPlex 2200 HIV Ag-Ab assay is intended for use with the BioPlex 2200 System.
Product Owner
Name
Bio-Rad Laboratories, Inc.
Short Name
Bio-Rad
Address
4000 Alfred Nobel Drive, Hercules, California 94547, 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)
BioPlex 2200 HIV Ag-Ab Calibrator Set BioPlex 2200 HIV Ag-Ab Control Set BioPlex 2200 HIV Ag-Ab Reagent Pack Assay Protocol File
Model Identifier(s)
6633400 6633430 6653450 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 HIV Ag-Ab 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 DE0504581 and owned by Bio-Rad Laboratories, Inc.. The device was registered on June 10, 2020.

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