HSA · registration DE0508709Phadia EliA Parietal Cell Well
SingaporeImmunologyClass BPhadia AB
Official record identity
- Registration number
- DE0508709
- Model name
- EliA Parietal Cell Well; EliA Gastric Positive Control 250; EliA Gastric Positive Control 200
- Model identifier
- 14-5669-01; 83-1145-01; 83-1168-01
- Registration date
- November 30, 2023
- Source update date
- October 08, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Phadia AB
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official description
EliA Parietal Cell is intended for the in vitro quantitative measurement of IgG antibodies directed to parietal cells in human serum and plasma (heparin, citrate, EDTA) to aid in the clinical diagnosis of pernicious anemia. EliA Parietal Cell uses the EliA IgG method on the instruments Phadia 200 and Phadia 250. EliA products are to be used in clinical laboratories by trained professionals only.
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.