Singapore HSA registration DE0016249
Phadia EliA Jo-1 Well
Singapore·CLASS B IVD·Phadia AB·Registered August 27, 2014Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0016249
- Registration Date
- August 27, 2014
- Change Notification Approval Date
- April 30, 2025
- Retention Due Date
- August 26, 2025
Product description
EliA Jo-1 is intended for the in vitro quantitative measurement of IgG antibodies directed to Jo-1 in human serum and plasma as an aid in the clinical diagnosis of polymyositis / dermatomyositis. EliA Jo-1 is to be used together with the EliA IgG method on the instruments Phadia 100 and Phadia 250.
Product Owner
- Name
- Phadia AB
- Short Name
- Phadia AB
- Address
- Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, SWEDEN
Registrant
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
- Model Name(s)
- EliA Jo-1 Well EliA IgG Calibrator Well EliA Dummy Well EliA IgG Calibrators EliA IgG Curve Control EliA IgG Conjugate EliA Sample Diluent EliA IgG Conjugate EliA IgG Calibrator Strips EliA IgG Curve Control Strips EliA IgG Conjugate 50 EliA IgG Conjugate 200 EliA Sample Diluent EliA ANA Positive Control 250 EliA IgG/IgM/IgA Negative Control 250 EliA ANA Positive Control 100 EliA IgG/IgM/IgA Negative Control 100
- Model Identifier(s)
- 14-5507-01 14-5509-01 14-5510-01 83-1000-01 83-1001-01 83-1002-01 83-1003-01 83-1005-01 83-1015-01 83-1016-01 83-1017-01 83-1018-01 83-1023-01 83-1033-01 83-1037-01 83-1038-01 83-1042-01
About this record
Access comprehensive regulatory information for Phadia EliA Jo-1 Well 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 DE0016249 and owned by Phadia AB. The device was registered on August 27, 2014.
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