HSA · registration DE0019009Phadia ImmunoCAP Total IgE
SingaporeImmunologyClass BPhadia AB
Official record identity
- Registration number
- DE0019009
- Model name
- 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 IgE/ECP/Tryptase Sample Diluent; ImmunoCAP Total IgE Anti-IgE
- Model identifier
- 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; 10-9517-03; 10-9541-01; 14-4509-01
- Registration date
- February 23, 2017
- Source update date
- December 18, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Phadia AB
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official 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.
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.