Medical Device Division · registration 240353ActivePHADIA
Hong KongIVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin GIVD Class BPHADIA AB
Official record identity
- MDACS listing number
- 240353
- Model name
- ELIA DSDNA WELL (14-5500-01), ELIA U1RNP WELL (14-5501-01), ELIA RO WELL (14-5503-01), ELIA LA WELL (14-5504-01), ELIA CENP WELL (14-5505-01), ELIA JO-1 WELL (14-5507-01), ELIA RNP70 WELL (14-5511-01), ELIA RIB-P WELL (14-5521-01), ELIA CTD SCREEN WELL (14-5596-01), ELIA MI-2 WELL (14-5604-01), ELIA SCL-70S WELL (14-5637-01), ELIA RNA POL III WELL (14-5599-01), ELIA ANA POSITIVE CONTROL (83-1033-01, 83-1148-01)
- Registration date
- November 03, 2025
- Expiry date
- August 28, 2029
- Source update date
- November 04, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G
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 G
Additional source fields
- AMD nomenclature code
- 17372
- 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
- a
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.