230087
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
August 16, 2024
Expiry Date
March 02, 2028
Product Models
EliA Cardiolipin IgG (14-5529-01), EliA IgG Calibrator Well (14-5509-01), EliA APS Positive Control 200 (83-1151-01), EliA IgG Conjugate 50 (83-1017-01), EliA IgG Conjugate 200 (83-1018-01), EliA IgG Calibrator Strips (83-1015-01), EliA IgG Curve Control Strips (83-1016-01)
EliA ๅฟ็ฃท่ IgG (14-5529-01)ใEliA IgG ๆ กๅๅๅญ (14-5509-01)ใEliA APS ้ณๆงๅฏน็
งๅ 200 (83-1151-01)ใEliA IgG ๅถ่็ฉ 50 (83-1017-01)ใEliA IgG ๅถ่็ฉ 200 (83-1018-01)ใEliA IgG ๆ กๅๅๆก (83-1015-01)ใEliA IgG ๆฒ็บฟๅฏน็
งๆก (83-1016-01)