Medical Device Division · registration 230088ActivePHADIA
Hong KongIVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin MIVD Class BPHADIA AB
Official record identity
- MDACS listing number
- 230088
- Model name
- EliA Cardiolipin IgM (14-5530-01), EliA IgM Calibrator Well (14-5527-01),EliA IgM Conjugate 50 (83-1051-01), EliA IgM Conjugate 200 (83-1072-01), EliA IgM Calibrator Strips (83-1052-01), EliA IgM Curve Control Strips (83-1053-01)
- Registration date
- November 03, 2025
- Expiry date
- March 02, 2028
- Source update date
- November 05, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M
Official value: B
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- PHADIA AB
Official description
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M
Additional source fields
- AMD nomenclature code
- 17373
- Traditional Chinese local responsible person
- 賽默飛世爾科技(香港)有限公司
- Local responsible person phone
- 31077600
- Published manufacturer address
- Rapsgatan 7P PO. Box 6460, 751 37 UPPSALA SWEDEN
- Revision number
- b
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.