HSA · registration DE0016249Phadia EliA Jo-1 Well
SingaporeImmunologyClass BPhadia AB
Official record identity
- Registration number
- DE0016249
- Model name
- 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
- 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
- Registration date
- August 27, 2014
- Source update date
- April 30, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Phadia AB
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official 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.
Additional source fields
- Product owner address
- Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.