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Singapore HSA registration DE0503769

Bio-Rad BioPlex 2200 Celiac IgA and IgG

Singapore flagSingapore·CLASS B IVD·Bio-Rad Laboratories, Inc.·Registered October 23, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0503769
Registration Date
October 23, 2019
Change Notification Approval Date
December 03, 2024
Retention Due Date
October 22, 2025
Product description
The BioPlex® 2200 Celiac IgA and IgG kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgA and IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum or EDTA plasma. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy) and the associated skin disorder Dermatitis Herpetiformis (DH). The BioPlex 2200 Celiac IgA and IgG Reagent kits are intended for use with the Bio-Rad 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 Celiac IgG Calibrator Set BioPlex 2200 Celiac IgG Control Set BioPlex 2200 Celiac IgA Calibrator Set BioPlex 2200 Celiac IgA Control Set BioPlex 2200 Celiac IgG Reagent Pack BioPlex 2200 Celiac IgA Reagent Pack Assay Protocol File
Model Identifier(s)
6632200 6632230 6632300 6632330 6652250 6652350 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Celiac IgA and IgG 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 DE0503769 and owned by Bio-Rad Laboratories, Inc.. The device was registered on October 23, 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