HSA · registration DE0510569Phadia EliA anti-TSH-R Well
- Registration number
- DE0510569
- Model name
- EliA anti-TSH-R Well; EliA IgG/IgM/IgA Negative Control 250; EliA anti-TSH-R Conjugate 50; EliA anti-TSH-R Conjugate 200; EliA anti-TSH-R Calibrator Strips; EliA anti-TSH-R Curve Control Strips; EliA Thyroid Positive Control 250; EliA anti-TSH-R Sample Diluent
- Model identifier
- 14-5639-01; 83-1037-01; 83-1109-01; 83-1110-01; 83-1111-01; 83-1112-01; 83-1113-01; 83-1121-01
- Registration date
- April 08, 2025
- Risk class
- Class B
- Product owner
- Phadia AB
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
EliA anti-TSH-R is intended for the in vitro quantitative measurement of autoantibodies to the thyroid stimulating hormone receptor (TSH-R) in human serum and plasma (EDTA, heparin) using a thyroid stimulating monoclonal antibody, as an aid in the clinical diagnosis of Graves' disease (autoimmune hyperthyroidism). EliA anti-TSH-R uses the EliA anti-TSH-R method on the instrument Phadia 250. EliA products are to be used in clinical laboratories by trained professionals only.
- 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
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.