Singapore HSA registration DE0019150
Phadia ImmunoCAP Tryptase Fluoroenzymeimmunoassay
Singapore·CLASS B IVD·Phadia AB·Registered April 10, 2017Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0019150
- Registration Date
- April 10, 2017
- Change Notification Approval Date
- May 12, 2024
- Retention Due Date
- April 09, 2026
Product description
ImmunoCAP Tryptase is an immunoassay for the quantitative measurement of tryptase in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of systemic mastocytosis and mast cell activation events, in conjunction with other clinical findings. ImmunoCAP Tryptase is to be used in clinical laboratories and with the instruments Phadia 100, Phadia 250 or Phadia 1000.
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 IgE/ECP/Tryptase Sample Diluent ImmunoCAP Tryptase Control ImmunoCAP Tryptase Conjugate 50 ImmunoCAP Tryptase Calibrator Strip ImmunoCAP Tryptase Curve Control Strip ImmunoCAP Tryptase (Conjugate, Curve Control) ImmunoCAP Tryptase Calibrators ImmunoCAP Tryptase Curve Control ImmunoCAP IgE/ECP/Tryptase Sample Diluent ImmunoCAP Tryptase Anti-Tryptase
- Model Identifier(s)
- 10-9256-01 10-9360-01 10-9370-01 10-9522-01 10-9523-01 10-9524-01 10-9525-01 10-9526-01 10-9527-01 10-9541-01 14-4518-01
About this record
Access comprehensive regulatory information for Phadia ImmunoCAP Tryptase Fluoroenzymeimmunoassay 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 DE0019150 and owned by Phadia AB. The device was registered on April 10, 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