Singapore HSA registration DE0510215
Bio-Rad Biotestcell-A1& B, A2, O
Singapore·CLASS D IVD·Bio-Rad Medical Diagnostics GmbH·Registered January 07, 2025Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510215
- Registration Date
- January 07, 2025
- Retention Due Date
- January 06, 2026
Product description
Biotestcell-A1 & B, A2 are Reagent Red Blood Cells intended to be used for the qualitative detection of human ABO antibodies in donor and patient (recipient) plasma/serum in the manual slide/tile and tube method. Biotestcell-O are Reagent Red Blood Cells intended to be used for the qualitative detection of human non-ABO agglutinins, including anti-H in donor and patient (recipient) plasma/serum within ABO reverse grouping in the manual slide/tile and tube method. Whole blood collected in EDTA, citrate or without anticoagulant may be used. For in vitro diagnostic use, by trained laboratory personnel.
Product Owner
- Short Name
- Bio-Rad Medical Diagnostics GmbH
- Address
- Industriestr. 1,, 63303 Dreieich, GERMANY
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)
- Biotestcell-O Biotestcell-A2 Biotestcell-A1 & B
- Model Identifier(s)
- 12012453 12012454 12012455
About this record
Access comprehensive regulatory information for Bio-Rad Biotestcell-A1& B, A2, O 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 DE0510215 and owned by Bio-Rad Medical Diagnostics GmbH. The device was registered on January 07, 2025.
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