Singapore HSA registration DE0019008
Phadia ImmunoCAP Total IgE Low Range
Singapore·CLASS B IVD·Phadia AB·Registered February 23, 2017Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0019008
- Registration Date
- February 23, 2017
- Change Notification Approval Date
- June 30, 2022
- Retention Due Date
- February 22, 2026
Product description
ImmunoCAP Total IgE Low Range is an in vitro test system for the quantitative measurement of low concentrations 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.
Product Owner
- Name
- Phadia AB
- 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 IgE/ECP/Tryptase Sample Diluent ImmunoCAP Specific IgE Conjugate 400 ImmunoCAP Specific IgE Conjugate 400 ImmunoCAP Specific IgE Curve Control Strip ImmunoCAP Specific IgE Conjugate 100 ImmunoCAP IgE/ECP/Tryptase Sample Diluent ImmunoCAP Specific IgE Curve Controls ImmunoCAP Specific IgE Calibrator Strip ImmunoCAP Specific IgE Calibrators ImmunoCAP Specific IgE (Conjugate, Curve Controls) ImmunoCAP Specific IgE (Conjugate, Curve Controls) ImmunoCAP Specific IgE Conjugate ImmunoCAP IgE/ECP/Tryptase Sample Diluent ImmunoCAP Specific IgE Anti-IgE ImmunoCAP Total IgE Low Range
- Model Identifier(s)
- 10-9256-01 10-9310-01 10-9310-03 10-9312-01 10-9316-01 10-9360-01 10-9408-01 10-9459-01 10-9460-01 10-9462-01 10-9462-03 10-9463-01 10-9541-01 14-4417-01 14-4497-35
About this record
Access comprehensive regulatory information for Phadia ImmunoCAP Total IgE Low Range 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 DE0019008 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD