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Singapore HSA registration DE0014864

Bio-Rad Monolisa HCV Ag-Ab ULTRA V2

Singapore flagSingapore·CLASS D IVD·Bio-Rad·Registered February 28, 2014
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0014864
Registration Date
February 28, 2014
Change Notification Approval Date
November 01, 2023
Retention Due Date
February 27, 2026
Product description
The Monolisa HCV Ag-Ab ULTRA V2 assay is a semi- quantitative enzyme immunoassay kit for the detection of Hepatitis C Virus (HCV) core antigen and antibodies in human serum or plasma specimens. This kit can be used for the screening of blood donations and as an aid in the diagnosis of hepatitis C infection. The Monolisa HCV Ag-Ab ULTRA V2 assay can be used manually or on automated systems.
Product Owner
Name
Bio-Rad
Short Name
Bio-Rad
Address
3, bvd 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
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
Monolisa HCV Ag-Ab ULTRA V2 Monolisa™ HCV Ag-Ab ULTRA V2 Concentrated Washing Solution R2
Model Identifier(s)
72561 72562 72700
About this record

Access comprehensive regulatory information for Bio-Rad Monolisa HCV Ag-Ab ULTRA 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 DE0014864 and owned by Bio-Rad. The device was registered on February 28, 2014.

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