Singapore HSA registration DE0505233
SEBIA CAPI 3 HEMOGLOBIN(E)
Singapore·CLASS B IVD·SEBIA·Registered December 09, 2020Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0505233
- Registration Date
- December 09, 2020
- Retention Due Date
- December 08, 2025
Product description
The CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 3 instrument.The CAPILLARYS 3 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of whole blood samples collected in tubes containing KEDTA as anticoagulant. For In Vitro Diagnostic Use.
Product Owner
- Name
- SEBIA
- Short Name
- SEBIA
- Address
- Parc Technologique, Léonard de Vinci, CP 8010 – Lisses, 91008 EVRY CEDEX, FRANCE
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
- Model Name(s)
- CAPILLARYS 3 OCTA CAPILLARYS 3 TERA CAPI 3 HEMOGLOBIN(E) NORMAL Hb A2 CONTROL (5) PATHOLOGICAL Hb A2 CONTROL Hb AFSC CONTROL
- Model Identifier(s)
- 1245 1246 2507 4778 4779 4792
About this record
Access comprehensive regulatory information for SEBIA CAPI 3 HEMOGLOBIN(E) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0505233 and owned by SEBIA. The device was registered on December 09, 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 B IVD