IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A

体外诊断测试试剂/试剂盒、免疫测定、蛋白质、免疫球蛋白A

PHADIA AB·B·Hong Kong MDACS·Registered August 16, 2024

Device overview

Risk class: B
Product code: 17369
State: current
Status: N/A
Product code detail: 17369 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A

Manufacturer (製造商)

Name: PHADIA AB
Phadia 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 Cardiolipin IgA (14-5528-01), EliA IgA Calibrator Well (14-5516-01), EliA Dummy Well (14-5510-01), EliA IgG/IgM/IgA Negative Control 200 (83-1157-01), EliA Sample Diluent (83-1144-01), EliA IgA Conjugate 50 (83-1021-01), EliA IgA Conjugate 200 (83-1022-01), EliA IgA Calibrator Strips (83-1019-01), EliA IgA Curve Control Strips (83-1020-01), EliA APS Positive Control 250 (83-1055-01), EliA IgG/IgM/IgA Negative Control 250 (83-1037-01), EliA Sample Diluent (83-1023-01)

EliA 心磷脂 IgA (14-5528-01)、EliA IgA 校准孔 (14-5516-01)、EliA 虚拟孔 (14-5510-01)、EliA IgG/IgM/IgA 阴性对照 200 (83-1157-01)、EliA 样品稀释剂 (83-1144-01)、EliA IgA 偶联物 50 (83-10202) 1-01)、EliA IgA 偶联物 200 (83-1022-01)、EliA IgA 校准品条 (83-1019-01)、EliA IgA 曲线对照条 (83-1020-01)、EliA APS 阳性对照品 250 (83-1055-01)、EliA IgG/IgM/IgA 阴性对照品 250 (83-1037-01)、 EliA 样品稀释剂 (83-1023-01)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A. 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 A

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A