HSA · registration DE0509553Phadia EliA LKM-1 Wells
- Registration number
- DE0509553
- Model name
- EliA LKM-1; EliA AIH Positive Control 200; EliA AIH Positive Control 250
- Model identifier
- 14-6648-01; 83-1172-01; 83-1173-01
- Registration date
- July 19, 2024
- Risk class
- Class B
- Product owner
- Phadia AB
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
EliA LKM-1 is intended for the in vitro quantitative measurement of antibodies directed to liver-kidney microsomal antigen, identified as Cytochrome P450 2D6 (CYP2D6), in human serum and plasma (heparin, citrate, EDTA) to aid in the diagnosis of autoimmune hepatitis, type 2. EliA LKM-1 uses the EliA IgG method on the instrument Phadia 200. 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.