HSA · registration DE0019008Phadia ImmunoCAP Total IgE Low Range
SingaporeImmunologyClass BPhadia AB
Official record identity
- Registration number
- DE0019008
- Model name
- 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 Calibrator Strip; ImmunoCAP Specific IgE (Conjugate, Curve Controls); ImmunoCAP IgE/ECP/Tryptase Sample Diluent; ImmunoCAP Specific IgE Anti-IgE; ImmunoCAP Total IgE Low Range
- Model identifier
- 10-9310-01; 10-9310-03; 10-9312-01; 10-9316-01; 10-9360-01; 10-9459-01; 10-9462-03; 10-9541-01; 14-4417-01; 14-4497-35
- 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 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.
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.