Singapore HSA registration DE0011902
Bio-Check EBV EA+EBNA-1 IgA ELISA Kit
Singapore·CLASS C IVD·BIO-CHECK LABORATORIES LTD·Registered December 20, 2012Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0011902
- Registration Date
- December 20, 2012
- Retention Due Date
- December 19, 2025
Product description
It is an enzyme linked immunosorbent assay intended for the qualitative or quantitative detection of IgA antibodies against the early antigen and nuclear antigen of the Epstein-Barr virus contained in human serum
Product Owner
- Short Name
- BIO-CHECK LABORATORIES LTD
- Address
- 10F, No 8 Lane 348, Sec 2,, Chung-Shan Road, Chung-Ho, Taipei,, taiwan 235, TAIWAN
Registrant
- Name
- LABOTECH PTE LTD
- Address
- 300 TAMPINES AVENUE 5, INCOME AT TAMPINES JUNCTION, #09-02, SINGAPORE 529653
Importer
- Name
- LABOTECH PTE LTD
- Address
- 239B VICTORIA STREET, SINGAPORE 188029
Model information
- Model Name(s)
- Substrate A Substrate B Conjugate Conjugate Diluent Serum Diluent Stop Solution Control A Control B Control C Negative Control 20X Conc.Washing Solution ELISA PLATE EBV EA+EBNA-1 IgA ELISA kit
- Model Identifier(s)
- EB9601 EB9602 EB9603 EB9604 EB9605 EB9606 EB9607 EB9608 EB9609 EB9610 EB9611 EB9612 EBV EA+EBNA-1
About this record
Access comprehensive regulatory information for Bio-Check EBV EA+EBNA-1 IgA ELISA Kit 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 DE0011902 and owned by BIO-CHECK LABORATORIES LTD. The device was registered on December 20, 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 C IVD