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Singapore HSA registration DE0504435

Bio-Rad BioPlex 2200 EBV IgM

Singapore flagSingapore·CLASS C IVD·Bio-Rad Laboratories, Inc.·Registered May 05, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0504435
Registration Date
May 05, 2020
Change Notification Approval Date
December 27, 2024
Retention Due Date
May 04, 2026
Product description
The BioPlex® 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen IgM (EBV VCA IgM) antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The EBV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt’s lymphoma, and other EBV-associated lymphomas.
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 EBV IgM Calibrator Set BioPlex 2200 EBV IgM Control Set BioPlex 2200 EBV IgM Reagent Pack Assay Protocol File
Model Identifier(s)
6631300 6631330 6651350 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 EBV 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 DE0504435 and owned by Bio-Rad Laboratories, Inc.. The device was registered on May 05, 2020.

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