Singapore HSA registration DE0505680
Bio-Rad BioPlex 2200 MMV IgM Reagent Pack
Singapore·CLASS C IVD·Bio-Rad Laboratories·Registered April 20, 2021Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0505680
- Registration Date
- April 20, 2021
- Change Notification Approval Date
- December 27, 2024
- Retention Due Date
- April 19, 2026
Product description
The BioPlex 2200 MMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgM antibodies to measles, mumps, and varicella-zoster virus (VZV) in human serum or plasma. The BioPlex 2200 MMV IgM kit is intended as an aid in the determination of serological status to measles, mumps and VZV.This assay is not intended for use in screening blood, plasma or tissue donors. The BioPlex 2200 MMV IgM kit is intended for use with the BioPlex 2200 system.
Product Owner
- Short Name
- Bio-Rad Laboratories
- Address
- 4000 Alfred Nobel Drive, 94547 Hercules - CA., UNITED STATES
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- BioPlex 2200 MMV lgM Reagent Pack BioPlex 2200 MMV lgM Control Set BioPlex 2200 MMV lgM Calibrator Set Assay Protocol File
- Model Identifier(s)
- 12000930 12000931 12000933 Assay Protocol File
About this record
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 MMV IgM Reagent Pack 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 DE0505680 and owned by Bio-Rad Laboratories. The device was registered on April 20, 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