240408
B
current
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin Gไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝ G
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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝ G
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17372
Product Code Detail
17372 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
PHADIA AB
Phadia Ab
Rapsgatan 7P PO. Box 6460, 751 37 UPPSALA SWEDEN
ๆๆฎๆฏๅ ๅฆ 7P PO.ๆก 6460, 751 37 ไนๆฎ่จๆ็ๅ
ธ
Authorised Representative (AR)
Thermo Fisher Scientific (Hong Kong) Limited
่ต้ป้ฃไธๅฐ็งๆ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
31077600
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
ELIA GBM WELL (14-5514-01), ELIA PR3S WELL (14-5536-01), ELIA MPOS WELL (14-5537-01), ELIA ANCA/GBM POSITIVE CONTROL (83-1034-01, 83-1149-01)
ELIA GBM WELL (14-5514-01), ELIA PR3S WELL (14-5536-01), ELIA MPOS WELL (14-5537-01), ELIA ANCA / GBM ้ณๆงๅฏน็
ง (83-1034-01, 83-1149-01)