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HSA · registration DE0506009

Phadia EliA SymphonyS Well

SingaporeImmunologyClass BPhadia AB
Verified
Official record identity
Registration number
DE0506009
Model name
EliA IgG Calibrator Well; EliA Dummy Well; EliA SymphonyS 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/IgA/IgM Negative Control 250; EliA ANA Positive Control 100; EliA IgG/IgM/IgA Negative Control 100; EliA Sample Diluent; EliA ANA Positive Control 200; EliA IgG/IgA/IgM Negative Control 200
Model identifier
14-5509-01; 14-5510-01; 14-5671-01; 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; 83-1144-01; 83-1148-01; 83-1157-01
Registration date
July 23, 2021
Source update date
April 30, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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Published parties
Product owner
Phadia AB
Registrant / registration holder
BIOMED DIAGNOSTICS PTE LTD
Official description

EliA SymphonyS is intended for the in vitro qualitative measurement of antinuclear IgG antibodies in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis. EliA SymphonyS uses the EliA IgG method on the instrument Phadia 100, 200, 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.