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Phadia EliA LKM-1 Wells - HSA Registration DE0509553

Access comprehensive regulatory information for Phadia EliA LKM-1 Wells 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 DE0509553 and owned by Phadia AB. The device was registered on July 19, 2024.

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
DE0509553
Phadia EliA LKM-1 Wells
HSA Registration Number: DE0509553
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Product Description

EliA LKM-1 is intended for the in vitro quantitative measurement of antibodies directed to liver-kidney microsomal antigen, identified as Cytochrome P450 2D6 (CYP2D6), in human serum and plasma (heparin, citrate, EDTA) to aid in the diagnosis of autoimmune hepatitis, type 2. EliA LKM-1 uses the EliA IgG method on the instrument Phadia 200. EliA products are to be used in clinical laboratories by trained professionals only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509553
Registration Date
July 19, 2024
Retention Due Date
July 18, 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 LKM-1 EliA AIH Positive Control 200 EliA AIH Positive Control 250
Model Identifier(s)
14-6648-01 83-1172-01 83-1173-01