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Phadia ImmunoCAP Total IgE - HSA Registration DE0019009

Access comprehensive regulatory information for Phadia ImmunoCAP Total IgE 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 DE0019009 and owned by Phadia AB. The device was registered on February 23, 2017.

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
DE0019009
Phadia ImmunoCAP Total IgE
HSA Registration Number: DE0019009
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Product Description

ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0019009
Registration Date
February 23, 2017
Change Notification Approval Date
October 10, 2019
Retention Due Date
February 22, 2026
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)
ImmunoCAP Total IgE Calibrators ImmunoCAP IgE/ECP/Tryptase Sample Diluent ImmunoCAP Total IgE Curve Controls Quality Club Total IgE Quality Club Total IgE ImmunoCAP Total IgE Conjugate 100 ImmunoCAP Total IgE Conjugate 100 ImmunoCAP Total IgE Curve Control Strip ImmunoCAP IgE/ECP/Tryptase Sample Diluent ImmunoCAP Total IgE Calibrator Strip ImmunoCAP Total IgE Control LMH ImmunoCAP Total IgE Control LMH ImmunoCAP Total IgE Conjugate 400 ImmunoCAP Total IgE (Conjugate, Curve Controls) ImmunoCAP Total IgE (Conjugate, Curve Controls) ImmunoCAP IgE/ECP/Tryptase Sample Diluent ImmunoCAP Total IgE Anti-IgE
Model Identifier(s)
10-9252-01 10-9256-01 10-9257-01 10-9297-01 10-9297-03 10-9319-01 10-9319-03 10-9325-01 10-9360-01 10-9387-01 10-9447-01 10-9447-03 10-9480-01 10-9517-01 10-9517-03 10-9541-01 14-4509-01