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HSA · registration DE0508704

Phadia EliA Intrinsic Factor Well

SingaporeImmunologyClass BPhadia AB
Verified
Official record identity
Registration number
DE0508704
Model name
EliA Intrinsic Factor Well; EliA Gastric Positive Control 250; EliA Gastric Positive Control 200
Model identifier
14-5668-01; 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 category
Immunology
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Published parties
Product owner
Phadia AB
Registrant / registration holder
BIOMED DIAGNOSTICS PTE LTD
Official description

EliA Intrinsic Factor is intended for the in vitro quantitative measurement of IgG antibodies directed to intrinsic factor in human serum and plasma (heparin, citrate, EDTA) to aid in the clinical diagnosis of pernicious anemia. EliA Intrinsic Factor 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.