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Singapore HSA registration DE0510569

Phadia EliA anti-TSH-R Well

Singapore flagSingapore·CLASS B IVD·Phadia AB·Registered April 08, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510569
Registration Date
April 08, 2025
Retention Due Date
April 07, 2026
Product description
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
Name
Phadia AB
Short Name
Phadia AB
Address
Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, SWEDEN
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
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(s)
14-5639-01 83-1037-01 83-1109-01 83-1110-01 83-1111-01 83-1112-01 83-1113-01 83-1121-01
About this record

Access comprehensive regulatory information for Phadia EliA anti-TSH-R Well in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510569 and owned by Phadia AB. The device was registered on April 08, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD