240263
B
current
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin Aไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝA
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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝA
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17369
Product Code Detail
17369 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
PHADIA AB
Phadia Ab
RAPSGATAN 7P, P.O. Box 6460, UPPSALA, SWEDEN. 75137
RAPSGATAN 7P, P.O. Box 6460, ไนๆฎ่จๆ, ็ๅ
ธ.75137
Authorised Representative (AR)
Thermo Fisher Scientific (Hong Kong) Limited
่ต้ป้ฃไธๅฐ็งๆ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
31077600
Regulatory Timeline
Registration Date
July 23, 2024
Expiry Date
July 22, 2029
Product Models
ELIA CELIKEY IGA WELL (14-5517-01), ELIA CELIAC POSITIVE CONTROL (83-1036-01, 83-1156-01)
ELIA CELIKEY IGA WELL (14-5517-01), ELIA ไนณ็ณๆณป้ณๆงๅฏน็
ง (83-1036-01, 83-1156-01)