230091
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M
体外诊断 测试试剂/试剂盒、免疫测定、蛋白质、免疫球蛋白 M
PHADIA AB·B·Hong Kong MDACS·Registered August 16, 2024
Device overview
- Risk class
- B
- Product code
- 17373
- State
- current
- Status
- N/A
- Product code detail
- 17373 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M
Manufacturer (製造商)
- Name
- PHADIA ABPhadia Ab
- Address
- Rapsgatan 7P PO. Box 6460, 751 37 UPPSALA SWEDEN拉普斯加坦 7P PO.框 6460, 751 37 乌普萨拉瑞典
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 16, 2024
- Expiry date
- March 02, 2028
Product models
EliA β2-Glycoprotein I IgM (14-5533-01)
EliA β2-糖蛋白 I IgM (14-5533-01)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M. 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 M
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 M