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Singapore HSA registration DE0503768

Bio-Rad BioPlex 2200 APLS IgG, IgM and IgA

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
DE0503768
Registration Date
October 23, 2019
Change Notification Approval Date
February 18, 2025
Retention Due Date
October 22, 2025
Product description
The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgG, IgM and IgA kits are multiplex flow immunoassays intended for the semiquantitative detection of IgG, IgM and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (ß2GPI) in human serum and heparinized or citrated plasma. In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The BioPlex 2200 APLS IgG, IgM and IgA 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 APLS IgG Calibrator Set BioPlex 2200 APLS IgG Control Set BioPlex 2200 APLS IgM Calibrator Set BioPlex 2200 APLS IgM Control Set BioPlex 2200 APLS IgA Calibrator Set BioPlex 2200 APLS IgA Control Set BioPlex 2200 APLS IgG Reagent Pack BioPlex 2200 APLS IgM Reagent Pack BioPlex 2200 APLS IgA Reagent Pack Assay Protocol File
Model Identifier(s)
6631900 6631930 6632000 6632030 6632100 6632130 6651950 6652050 6652150 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 APLS IgG, IgM and IgA 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 DE0503768 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