Pure Global

Phadia ImmunoCAP Tryptase Fluoroenzymeimmunoassay - HSA Registration DE0019150

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0019150
Phadia ImmunoCAP Tryptase Fluoroenzymeimmunoassay
HSA Registration Number: DE0019150
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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 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