Singapore HSA registration DE0503681
Bio-Rad BioPlex 2200 Syphilis Total & RPR
Singapore·CLASS D IVD·Bio-Rad Laboratories·Registered October 01, 2019Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0503681
- Registration Date
- October 01, 2019
- Change Notification Approval Date
- December 03, 2024
- Retention Due Date
- September 30, 2025
Product description
The BioPlex 2200 Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of Total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. The test system can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of syphilis infection. The BioPlex 2200 Syphilis Total & RPR kit is also intended for use in screening blood or plasma donors for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum. The BioPlex 2200 Syphilis Total & RPR kit is intended for use with the Bio‑Rad 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 Syphilis Total & RPR BioPlex 2200 Syphilis Total & RPR Calibrator Set BioPlex 2200 Syphilis Total & RPR Control Set BioPlex 2200 Sample Dilution Buffer Assay Protocol File
- Model Identifier(s)
- 12000650 12000651 12000653 12006863 Assay Protocol File
About this record
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Syphilis Total & RPR in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0503681 and owned by Bio-Rad Laboratories. The device was registered on October 01, 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 D IVD