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Phadia EliA Jo-1 Well - HSA Registration DE0016249

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.

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CLASS B IVD
DE0016249
Phadia EliA Jo-1 Well
HSA Registration Number: DE0016249
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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.

Device 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 Owner
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