Singapore HSA registration DE0009823
Biokit Quantia lgE Assay (LN 6K42, 6K50 and 6K56)
Singapore·CLASS B IVD·Biokit S.A.·Registered August 31, 2012Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0009823
- Registration Date
- August 31, 2012
- Change Notification Approval Date
- October 06, 2022
- Retention Due Date
- August 30, 2025
Product description
The reagents Quantia IgE are intended for the quantitative determination of immunoglobulin E (IgE) in human serum or plasma using the Abbott AEROSET® and ARCHITECT cSystems™.
Product Owner
- Name
- Biokit S.A.
- Short Name
- Biokit S.A.
- Address
- Av. Can Montcau 7, 08186 Lliçà d'Amunt, Barcelona, SPAIN
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- Quantia lgE Quantia lgE Quantia lgE Standard Quantia lgE Standard Quantia Ferritin/ Myoglobin/ lgE Control Quantia Ferritin/ Myoglobin/ lgE Control
- Model Identifier(s)
- 6K42-01 6K42-02 6K50-01 6K50-03 6K56-01 6K56-02
About this record
Access comprehensive regulatory information for Biokit Quantia lgE Assay (LN 6K42, 6K50 and 6K56) 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 DE0009823 and owned by Biokit S.A.. The device was registered on August 31, 2012.
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