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Singapore HSA registration DE0503155

Bio-Rad BioPlex 2200 Vasculitis Reagent Pack

Singapore flagSingapore·CLASS B IVD·Bio-Rad Laboratories·Registered May 28, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0503155
Registration Date
May 28, 2019
Change Notification Approval Date
December 27, 2024
Retention Due Date
May 27, 2025
Product description
The BioPlex® 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum. In conjunction with clinical findings, the test system is used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides: Microscopic Polyangiitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener’s Granulomatosis and the autoimmune renal disorder, Goodpasture’s syndrome. The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System.
Product Owner
Name
Bio-Rad Laboratories
Short Name
Bio-Rad Laboratories
Address
4000 Alfred Nobel Drive, 94547 Hercules - CA., 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 Vasculitis Calibrator Set BioPlex 2200 Vasculitis Control Set BioPlex 2200 Vasculitis Reagent Pack Assay Protocol File
Model Identifier(s)
6631800 6631830 6651850 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Vasculitis Reagent Pack in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0503155 and owned by Bio-Rad Laboratories. The device was registered on May 28, 2019.

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 B IVD