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HSA · registration DE0019150

Phadia ImmunoCAP Tryptase Fluoroenzymeimmunoassay

SingaporeImmunologyClass BPhadia AB
Verified
Official record identity
Registration number
DE0019150
Model name
ImmunoCAP IgE/ECP/Tryptase Sample Diluent; ImmunoCAP Tryptase Control; ImmunoCAP Tryptase Conjugate 50; ImmunoCAP Tryptase Calibrator Strip; ImmunoCAP Tryptase Curve Control Strip; ImmunoCAP IgE/ECP/Tryptase Sample Diluent; ImmunoCAP Tryptase Anti-Tryptase
Model identifier
10-9360-01; 10-9370-01; 10-9522-01; 10-9523-01; 10-9524-01; 10-9541-01; 14-4518-01
Registration date
April 10, 2017
Source update date
December 18, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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Published parties
Product owner
Phadia AB
Registrant / registration holder
BIOMED DIAGNOSTICS PTE LTD
Official 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 250 or Phadia 1000.

Additional source fields
Product owner address
Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden
Registrant address
18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.