230089
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 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
August 16, 2024
Expiry Date
March 02, 2028
Product Models
EliA ฮฒ2-Glycoprotein I IgA (14-5531-01)
EliA ฮฒ2-็ณ่็ฝ I IgA (14-5531-01)