240353
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G
体外诊断 测试试剂/试剂盒、免疫测定、蛋白质、免疫球蛋白 G
PHADIA AB·B·Hong Kong MDACS·Registered August 29, 2024
Device overview
- Risk class
- B
- Product code
- 17372
- State
- current
- Status
- N/A
- Product code detail
- 17372 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G
Manufacturer (製造商)
- Name
- PHADIA ABPhadia Ab
- Address
- RAPSGATAN 7P, P.O. Box 6460, UPPSALA, SWEDEN, 75137RAPSGATAN 7P, P.O. Box 6460, 乌普萨拉, 瑞典, 75137
Authorised representative (AR)
- Name
- Thermo Fisher Scientific (Hong Kong) Limited赛默飞世尔科技(香港)有限公司
- Phone
- 31077600
Regulatory timeline
- Registration date
- August 29, 2024
- Expiry date
- August 28, 2029
Product models
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)
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) 1-01)、ELIA RIB-P 孔 (14-5521-01)、ELIA CTD 筛选孔 (14-5596-01)、ELIA MI-2 孔 (14-5604-01)、ELIA SCL-70S 孔 (14-5637-01)、ELIA RNA POL III 孔 (14-5599-01)、ELIA ANA 阳性对照 (83-1033-01, 83-1148-01)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、蛋白质、免疫球蛋白 G