240353
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, 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
August 29, 2024
Expiry Date
August 28, 2029
Product Models
ELIA DSDNA WELL (14-5500-01), ELIA U1RNP WELL (14-5501-01), ELIA RO WELL (14-5503-01), ELIA LA WELL (14-5504-01), ELIA CENP WELL (14-5505-01), ELIA JO-1 WELL (14-5507-01), ELIA RNP70 WELL (14-5511-01), ELIA RIB-P WELL (14-5521-01), ELIA CTD SCREEN WELL (14-5596-01), ELIA MI-2 WELL (14-5604-01), ELIA SCL-70S WELL (14-5637-01), ELIA RNA POL III WELL (14-5599-01), ELIA ANA POSITIVE CONTROL (83-1033-01, 83-1148-01)
ELIA DSDNA WELL (14-5500-01), ELIA U1RNP WELL (14-5501-01), ELIA RO WELL (14-5503-01), ELIA LA WELL (14-5504-01), ELIA CENP WELL (14-5505-01), ELIA JO-1 WELL (14-5507-01), ELIA RNP70 WELL (14-5511) 1-01)ใELIA RIB-P ๅญ (14-5521-01)ใELIA CTD ็ญ้ๅญ (14-5596-01)ใELIA MI-2 ๅญ (14-5604-01)ใELIA SCL-70S ๅญ (14-5637-01)ใELIA RNA POL III ๅญ (14-5599-01)ใELIA ANA ้ณๆงๅฏน็
ง (83-1033-01, 83-1148-01)