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Singapore HSA registration DE0506197

Bio-Rad Bioplex 2200 ToRC IgM

Singapore flagSingapore·CLASS C IVD·Bio-Rad Laboratories, Inc.·Registered September 22, 2021
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0506197
Registration Date
September 22, 2021
Change Notification Approval Date
December 27, 2024
Retention Due Date
September 21, 2025
Product description
The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and potassium EDTA or heparinized plasma. The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child-bearing age.
Product Owner
Name
Bio-Rad Laboratories, Inc.
Short Name
Bio-Rad Laboratories, Inc.
Address
4000 Alfred Nobel Drive, Hercules, CA 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 ToRC IgM Reagent Pack BioPlex 2200 ToRC IgM Calibrator Set BioPlex 2200 ToRC IgM Control Set Assay Protocol File
Model Identifier(s)
12000670 12000677 12000678 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad Bioplex 2200 ToRC IgM in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506197 and owned by Bio-Rad Laboratories, Inc.. The device was registered on September 22, 2021.

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 C IVD