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Bio-Rad BioPlex 2200 MMV IgM Reagent Pack - HSA Registration DE0505680

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.

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CLASS C IVD
DE0505680
Bio-Rad BioPlex 2200 MMV IgM Reagent Pack
HSA Registration Number: DE0505680
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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.

Device 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 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